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dateTime="2024-11-07T16:00:53.264">November 7, 2024</time></div><div class="flex items-center"><p class="text-gray-500 mt-[1px]">Psychiatric Times</p></div><div class="flex flex-wrap max-h-[24px] text-gray-500 mb-2"><span class="text-gray-500">Vol 41, Issue 11<div class="inline-block h-[16px] border-l-2 border-gray-400 mt-1 mx-1 relative top-[3px]"></div>Volume<span class="font-bold "></span></span></div><h1 class="text-[26px] font-medium leading-8">Schizophrenia Pharmacology: Version 2.0</h1><div class="py-3 text-gray-600 md:flex flex-col md:justify-between"><div class="flex flex-col xs:flex-row"><p class="mr-1 self-start">Author(s):</p><div class="flex flex-col xs:flex-row mb-3 md:mb-0"><div class="flex flex-wrap"><span class="text-md mr-2"><a class="text-author text-gray-500 hover:text-primary underline hover:no-underline decoration-gray-400" href="/authors/john-j-miller-md">John J. Miller, MD</a></span></div></div></div><div class="max-w-full"><div class="flex flex-wrap sm:flex-nowrap items-center w-fit "></div><div class="w-full flex flex-col sm:flex-row justify-between mt-2"><div class="block md:hidden "><div class="mt-2 flex items-center max-w-fit"><button title="Schizophrenia Pharmacology: Version 2.0" aria-label="facebook" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg viewBox="0 0 64 64" width="32" height="32"><circle cx="32" cy="32" r="31" fill="#3b5998"></circle><path d="M34.1,47V33.3h4.6l0.7-5.3h-5.3v-3.4c0-1.5,0.4-2.6,2.6-2.6l2.8,0v-4.8c-0.5-0.1-2.2-0.2-4.1-0.2 c-4.1,0-6.9,2.5-6.9,7V28H24v5.3h4.6V47H34.1z" fill="white"></path></svg></button><button aria-label="twitter" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg fill="#DC7633" xmlns="http://www.w3.org/2000/svg" width="32" zoomAndPan="magnify" viewBox="0 0 375 374.9999" height="32" preserveAspectRatio="xMidYMid meet" version="1.0"><defs><path d="M 7.09375 7.09375 L 367.84375 7.09375 L 367.84375 367.84375 L 7.09375 367.84375 Z M 7.09375 7.09375 " fill="#000000"></path></defs><g><path d="M 187.46875 7.09375 C 87.851562 7.09375 7.09375 87.851562 7.09375 187.46875 C 7.09375 287.085938 87.851562 367.84375 187.46875 367.84375 C 287.085938 367.84375 367.84375 287.085938 367.84375 187.46875 C 367.84375 87.851562 287.085938 7.09375 187.46875 7.09375 " fill-opacity="1" fill-rule="nonzero" fill="#000000"></path></g><g transform="translate(85, 75)"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 24 24" version="1.1" height="215" width="215"><path d="M18.244 2.25h3.308l-7.227 8.26 8.502 11.24H16.17l-5.214-6.817L4.99 21.75H1.68l7.73-8.835L1.254 2.25H8.08l4.713 6.231zm-1.161 17.52h1.833L7.084 4.126H5.117z" fill="#ffffff"></path></svg> </g></svg></button><button aria-label="linkedin" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg viewBox="0 0 64 64" width="32" height="32"><circle cx="32" cy="32" r="31" fill="#007fb1"></circle><path d="M20.4,44h5.4V26.6h-5.4V44z M23.1,18c-1.7,0-3.1,1.4-3.1,3.1c0,1.7,1.4,3.1,3.1,3.1 c1.7,0,3.1-1.4,3.1-3.1C26.2,19.4,24.8,18,23.1,18z M39.5,26.2c-2.6,0-4.4,1.4-5.1,2.8h-0.1v-2.4h-5.2V44h5.4v-8.6 c0-2.3,0.4-4.5,3.2-4.5c2.8,0,2.8,2.6,2.8,4.6V44H46v-9.5C46,29.8,45,26.2,39.5,26.2z" fill="white"></path></svg></button><button title="Schizophrenia Pharmacology: Version 2.0" aria-label="pinterest" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg viewBox="0 0 64 64" width="32" height="32"><circle cx="32" cy="32" r="31" fill="#cb2128"></circle><path d="M32,16c-8.8,0-16,7.2-16,16c0,6.6,3.9,12.2,9.6,14.7c0-1.1,0-2.5,0.3-3.7 c0.3-1.3,2.1-8.7,2.1-8.7s-0.5-1-0.5-2.5c0-2.4,1.4-4.1,3.1-4.1c1.5,0,2.2,1.1,2.2,2.4c0,1.5-0.9,3.7-1.4,5.7 c-0.4,1.7,0.9,3.1,2.5,3.1c3,0,5.1-3.9,5.1-8.5c0-3.5-2.4-6.1-6.7-6.1c-4.9,0-7.9,3.6-7.9,7.7c0,1.4,0.4,2.4,1.1,3.1 c0.3,0.3,0.3,0.5,0.2,0.9c-0.1,0.3-0.3,1-0.3,1.3c-0.1,0.4-0.4,0.6-0.8,0.4c-2.2-0.9-3.3-3.4-3.3-6.1c0-4.5,3.8-10,11.4-10 c6.1,0,10.1,4.4,10.1,9.2c0,6.3-3.5,11-8.6,11c-1.7,0-3.4-0.9-3.9-2c0,0-0.9,3.7-1.1,4.4c-0.3,1.2-1,2.5-1.6,3.4 c1.4,0.4,3,0.7,4.5,0.7c8.8,0,16-7.2,16-16C48,23.2,40.8,16,32,16z" fill="white"></path></svg></button><button aria-label="email" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg viewBox="0 0 64 64" width="32" height="32"><circle cx="32" cy="32" r="31" fill="#7f7f7f"></circle><path d="M17,22v20h30V22H17z M41.1,25L32,32.1L22.9,25H41.1z M20,39V26.6l12,9.3l12-9.3V39H20z" fill="white"></path></svg></button><a class="print-wrap flex justify-center items-center cursor-pointer"><svg id="print" xmlns="http://www.w3.org/2000/svg" width="24" height="24" fill="currentColor" class="print bi bi-printer" viewBox="0 0 16 16"> <path d="M2.5 8a.5.5 0 1 0 0-1 .5.5 0 0 0 0 1z"></path> <path d="M5 1a2 2 0 0 0-2 2v2H2a2 2 0 0 0-2 2v3a2 2 0 0 0 2 2h1v1a2 2 0 0 0 2 2h6a2 2 0 0 0 2-2v-1h1a2 2 0 0 0 2-2V7a2 2 0 0 0-2-2h-1V3a2 2 0 0 0-2-2H5zM4 3a1 1 0 0 1 1-1h6a1 1 0 0 1 1 1v2H4V3zm1 5a2 2 0 0 0-2 2v1H2a1 1 0 0 1-1-1V7a1 1 0 0 1 1-1h12a1 1 0 0 1 1 1v3a1 1 0 0 1-1 1h-1v-1a2 2 0 0 0-2-2H5zm7 2v3a1 1 0 0 1-1 1H5a1 1 0 0 1-1-1v-3a1 1 0 0 1 1-1h6a1 1 0 0 1 1 1z"></path></svg></a></div><style> .print-wrap { width: 32px; height: 32px; background: #7F7F7F; border-radius: 100%; } .print { background: #7F7F7F; color: white; padding: 2px; border-radius: 100%; } </style></div><style> video::cue { display: inline; background-color: #b8dcf6; padding: 2px 2px; } audio { height: 40px; } .rhap_container { width: 300px !important; border-radius: 100px !important; height: 40px !important; box-shadow: 0px 0px 2px 2px rgba(0,0,0,0.1); } .rhap_progress-section { width: 150px; margin-left: 35px; } .rhap_controls-section { position: relative; bottom: .75rem; } .rhap_time { font-size: 12px; color: rgb(0,55,103); } .rhap_progress-bar { color: rgb(0,55,103) !important; } .rhap_progress-filled { background-color: rgb(0,55,103) !important; } .rhap_progress-indicator { height: 15px; width: 5px; top: -5px; margin-left: 1px; background-color: rgb(0,55,103) !important; } .rhap_repeat-button { display: none; } .rhap_volume-bar, rhap_volume-button, .rhap_volume-indicator { background: rgb(0,55,103) !important; } .rhap_volume-bar { height: 2px; width: 35px; position: relative; left: 22px; bottom: 21px; } .rhap_volume-button { // width: 5px; // height: 5px; flex: 0 0 26px; position: relative; left: 22px; bottom: 21px; } .rhap_volume-button svg { height: 18px; width: 18px; } .rhap_volume-indicator { height: 8px; width: 8px; top: -2.75px } .rhap_button-clear { color: rgb(0,55,103) !important; } .rhap_play-pause-button { color: rgb(0,55,103) !important; font-size: 30px !important; width: 30px !important; height: 30px !important; position: relative; right: 90px; bottom: 22px; } .rhap_main-controls button { color: rgb(0,55,103) !important; } audio::-webkit-media-controls-play-button, video::-webkit-media-controls-play-button { -webkit-appearance: media-play-button; color: #b8dcf6; } audio::-webkit-media-controls-panel { background-color: white !important; color: #000; } audio::-webkit-media-controls-current-time-display, audio::-webkit-media-controls-time-remaining-display { font-size: 12px; } </style></div></div></div><div class=" lg:w-full flex flex-col lg:flex-row lg:items-center lg:justify-end"></div><div class="w-full flex flex-col px-4 py-4 border-t border-b border-solid border-gray-400 my-4 "><h3 class="text-primary text-xl font-semibold">Key Takeaways</h3><ul class="list-disc px-8"><li class="py-2 "> KarXT (Cobenfy) introduces a novel nondopaminergic mechanism for schizophrenia treatment, combining xanomeline and trospium to target muscarinic cholinergic receptors. </li><li class="py-2 "> Clinical trials demonstrated KarXT's efficacy and safety, showing significant improvement in PANSS scores without traditional antipsychotic adverse effects. </li><li class="py-2 hidden"> Cobenfy is not classified as an antipsychotic, lacking dopamine-2 receptor antagonism, and may offer benefits for cognitive and negative symptoms. </li><li class="py-2 hidden"> Prescribers must familiarize themselves with Cobenfy's unique properties, as it represents a shift in schizophrenia treatment towards muscarinic cholinergic pathways.</li></ul><span class="text-xs font-bold text-primary underline cursor-pointer mt-2 ml-4">SHOW MORE</span></div><p class="py-2 mb-2 text-sm italic text-gray-600">The medication treatment of schizophrenia has finally diversified to a novel neurotransmitter system: the muscarinic cholinergic system.</p><div class="py-2"><div class="blockText_blockContent__TbCXh"><div class=""><div style="width:50%;float:left;max-width:525px;margin:0 1.5rem 1.5rem 0;clear:both;cursor:" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%274581%27%20height=%272618%27/%3e"/></span><img alt="pharmacology" title="pharmacology" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="pharmacology" title="pharmacology" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2F35d1f00931670ff03617de6b210f8376e4210447-4581x2618.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 1x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2F35d1f00931670ff03617de6b210f8376e4210447-4581x2618.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><div id="image-caption" class="text-gray-500 italic"><div class="blockText_blockContent__TbCXh"><p class="pb-2">ipopba/AdobeStock</p></div></div><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/psychtimes/35d1f00931670ff03617de6b210f8376e4210447-4581x2618.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2">September 26, 2024, turned out to be a paradigm-changing day for the treatment of individuals with <a target="_blank" href="https://www.psychiatrictimes.com/topics/schizophrenia">schizophrenia</a>. KarXT (Cobenfy) was approved by the US Food and Drug Administration (FDA) after a 15-year journey that started with a young scientist’s remarkable vision for developing a medication with the first new mechanism of action since 1954 to treat individuals with schizophrenia. The name KarXT defines the story: a small start-up company named Karuna Therapeutics, Inc, hypothesized that by combining 2 well-established molecules—xanomeline and trospium—brain circuits associated with schizophrenia could be modulated by a novel nondopaminergic mechanism to improve symptoms and have an entirely different pharmacology than all the other medications currently approved to treat schizophrenia that were developed over the past 70 years.</p><p class="pb-2"><strong>The Visionary</strong></p><p class="pb-2">At age 27, Andrew Miller, who had just completed his chemical engineering doctorate, began to explore possible innovations for unmet needs in medicine. With no background in pharmacology or medicine, after much effort and investigation, Dr Miller became passionate about developing a new treatment for schizophrenia. Researching the existing literature on possible novel mechanisms of action, he identified an established model of treating cognitive and psychotic symptoms by agonizing 2 specific muscarinic cholinergic receptors (mAChRs) in the brain: M1 and M4. Back in the 1990s, Eli Lilly and Company studied xanomeline, a molecule that binds tightly to all 5 of the mAChRs and has significant agonism activity at the M1 and M4 receptors, as a possible treatment for cognitive function in Alzheimer disease. Significantly, xanomeline demonstrated improvement compared with placebo in cognitive function, and in an astounding and serendipitous finding, it also demonstrated improvements in psychotic symptoms in patients with Alzheimer disease. Subsequently, data from a study demonstrated improvement in psychosis and cognition in patients with schizophrenia. However, further development of xanomeline was abandoned due to the poor tolerability that is expected from a medication that agonizes the mAChRs in the peripheral nervous system, specifically nausea, vomiting, diarrhea, sweating, and salivation.</p><p class="pb-2">Thinking outside the metaphorical box, Dr Miller asked himself if adding an anticholinergic medication that could not cross the blood-brain barrier might just allow for the central M1 and M4 agonism while mitigating the peripheral mAChR adverse effects. Dr Miller and colleagues created a list of all existing candidate medication combinations, which numbered 7410. The first combination on that list was xanomeline and trospium—an anticholinergic medication the FDA approved in 2004 for overactive bladder. Dr Miller hypothesized that finding an optimal dosing combination of xanomeline and trospium could provide the central benefits for psychosis and cognition while minimizing the peripheral adverse events. The final obstacle in testing this hypothesis was a lack of financial resources, with only $4000 left in the bank account. At this point in the journey, Dr Miller was the only employee of Karuna, which was founded around the development of KarXT. He applied for funding from the Wellcome Trust, a philanthropic organization based in the United Kingdom, which awarded Karuna funding for the initial clinical trial with KarXT. With $5.5 million in hand, Dr Miller could assemble a team to investigate whether or not the xanomeline/trospium combination had a future in the treatment of individuals with schizophrenia.</p><p class="pb-2"><strong>KarXT Clinical Development</strong></p><p class="pb-2">The phase 2 clinical trial, named EMERGENT-1, was a 5-week double-blind placebo-controlled trial of KarXT in individuals with schizophrenia experiencing a significant relapse of symptoms, with an average Positive and Negative Syndrome Scale (PANSS) total score of 97, which places these patients in the “markedly ill” category. At the end of 5 weeks, the least square mean (LSM) improvement in total PANSS score, the primary outcome, in the KarXT group was 11.6 points greater than in the placebo group, with an effect size of 0.81.<sup class="text-inherit">1 </sup>This robust outcome paved the way for 2 more identically designed phase 3 trials (EMERGENT-2 and -3), the findings of which demonstrated a similar improvement in the total PANSS score compared with placebo, as well as strong effect sizes (LSM improvements, 9.6 points and 8.4 points; effect sizes, 0.61 and 0.60, respectively).<sup class="text-inherit">2,3</sup> Finally, 2 open-label, 52-week phase 3 studies designed to further assess the long-term safety, tolerability, and efficacy of KarXT in adult patients with schizophrenia were completed. Data from those studies, EMERGENT-4 and -5, supported the findings of the 5-week studies.<sup class="text-inherit">4,5</sup></p><p class="pb-2"><strong>Not an Antipsychotic</strong></p><p class="pb-2">Significantly, in the FDA product insert (PI), Cobenfy is defined as being “indicated for the treatment of schizophrenia in adults.”<sup class="text-inherit">6</sup> Throughout the PI, it is never referred to as an antipsychotic medication. This is notable, as the FDA has described all other medications currently approved to treat schizophrenia, from chlorpromazine (Thorazine) in 1954 to lumateperone (Caplyta) in 2019, as antipsychotics. A common property of all these antipsychotic medications is antagonism or antagonism/partial agonism of the dopamine-2 receptor (D2R), which has been hypothesized to be the mechanism that decreases the positive symptoms of schizophrenia, such as auditory hallucinations and delusions.</p><p class="pb-2">Schizophrenia has been well established as a syndrome with 3 primary symptom clusters—positive, negative, and cognitive symptoms. However, from 1954, when chlorpromazine became available in the United States, the treatment focus turned almost entirely to treatment of the positive symptoms because these responded to D2R blockade. Unfortunately, the antagonism of D2Rs in other parts of the brain comes at quite a cost, worsening the cognitive and negative symptoms (called secondary),<sup class="text-inherit">7</sup> muscle dystonia, akathisia, drug- induced parkinsonism, tardive dyskinesia, weight gain, sedation, prolactin elevation, neuroleptic malignant syndrome, and others. Cobenfy has not demonstrated any of these adverse events. It remains to be seen if Cobenfy improves cognitive and/or negative symptoms in schizophrenia. Additionally, Cobenfy has no boxed warnings from the FDA, and its adverse events, contraindications, warnings, and precautions documented in its PI are quite different from the antipsychotic medications we have been prescribing for the past 70 years. As a result, the prescriber has much to learn about this novel treatment option for individuals with schizophrenia. The interested reader can learn more about the putative mechanism of action of Cobenfy in <a target="_blank" href="https://www.psychiatrictimes.com/view/medication-pipeline-schizophrenia-and-ptsd">reference 8</a>.<sup class="text-inherit">8</sup></p><p class="pb-2"><strong>Adverse Events, Warnings</strong></p><p class="pb-2">Both xanomeline and trospium target the muscarinic cholinergic system, albeit oppositional to each other. Xanomeline has a strong affinity to all 5 mAChRs but significantly agonizes only 2: the M1 and the M4. Its action at these 2 mAChRs in the brain is hypothesized to decrease presynaptic dopamine release in the circuits relevant to schizophrenia while not affecting the circuits involved in motor function or hormones. In the peripheral nervous system, xanomeline demonstrates the expected adverse effects of nausea, vomiting, diarrhea, hypersalivation, and sweating. Trospium, which poorly crosses the blood-brain barrier, has minimal effects on the central nervous system but mitigates the procholinergic adverse effects of xanomeline in the peripheral nervous system through its anticholinergic activity. Not surprisingly, the common adverse events result from either procholinergic or anticholinergic activity, demonstrating the delicate balance that results from optimally dosing these 2 opposing mechanisms. <a target="_blank" href="https://www.psychiatrictimes.com/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2Fbfd7da2da86e0aee0aff179174f205eb06bdeaf8-250x638.png%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75"><strong>Table 1</strong></a> lists the common adverse events of Cobenfy.</p><div class=""><div style="width:49%;float:right;max-width:525px;margin:0 0 1.5rem 1.5rem;clear:both;cursor:" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%27250%27%20height=%27638%27/%3e"/></span><img alt="TABLE 1. Common Adverse Reactions to Cobenfy" title="TABLE 1. Common Adverse Reactions to Cobenfy" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="TABLE 1. Common Adverse Reactions to Cobenfy" title="TABLE 1. Common Adverse Reactions to Cobenfy" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2Fbfd7da2da86e0aee0aff179174f205eb06bdeaf8-250x638.png%3Ffit%3Dcrop%26auto%3Dformat&w=256&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2Fbfd7da2da86e0aee0aff179174f205eb06bdeaf8-250x638.png%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2Fbfd7da2da86e0aee0aff179174f205eb06bdeaf8-250x638.png%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><div id="image-caption" class="text-gray-500 italic"><div class="blockText_blockContent__TbCXh"><p class="pb-2"><strong>Table 1. </strong>Common Adverse Reactions to Cobenfy<sup class="text-inherit">6</sup></p></div></div><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/psychtimes/bfd7da2da86e0aee0aff179174f205eb06bdeaf8-250x638.png?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2">Xanomeline is extensively metabolized by the liver, and as a result, Cobenfy is contraindicated in the presence of moderate to severe hepatic impairment. CYP2D6 also metabolizes it, and the dose may need to be decreased in the presence of potent CYP2D6 inhibitors. Trospium, on the other hand, is minimally metabolized in the body, and approximately 90% of it is excreted unchanged in the urine. Hence Cobenfy is contraindicated in patients with urinary retention and is not recommended in patients with moderate to severe renal impairment. In these conditions, trospium serum levels are likely to increase, increasing the anticholinergic load. <a target="_blank" href="https://www.psychiatrictimes.com/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2F57be0ef1d9c109ce14292559ec271dbb4bbcc809-254x488.png%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75"><strong>Table 2</strong></a> lists the contraindications for Cobenfy.</p><div class=""><div style="width:50%;float:right;max-width:525px;margin:0 0 1.5rem 1.5rem;clear:both;cursor:" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%27254%27%20height=%27488%27/%3e"/></span><img alt="TABLE 2. Contraindications of Cobenfy" title="TABLE 2. Contraindications of Cobenfy" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="TABLE 2. Contraindications of Cobenfy" title="TABLE 2. Contraindications of Cobenfy" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2F57be0ef1d9c109ce14292559ec271dbb4bbcc809-254x488.png%3Ffit%3Dcrop%26auto%3Dformat&w=256&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2F57be0ef1d9c109ce14292559ec271dbb4bbcc809-254x488.png%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2F57be0ef1d9c109ce14292559ec271dbb4bbcc809-254x488.png%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><div id="image-caption" class="text-gray-500 italic"><div class="blockText_blockContent__TbCXh"><p class="pb-2"><strong>Table 2. </strong>Contraindications of Cobenfy<sup class="text-inherit">6</sup></p></div></div><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/psychtimes/57be0ef1d9c109ce14292559ec271dbb4bbcc809-254x488.png?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2">It is important to know about the presence of any other medication, prescribed or over the counter, that has anticholinergic activity. Benztropine, diphenhydramine, tricyclic antidepressants, clozapine, olanzapine, quetiapine, and chlorpromazine are some of the common medications our patients may be taking that have significant anticholinergic effects. Patients should be warned about the signs and symptoms of increased anticholinergic load.</p><p class="pb-2">It is crucial to instruct the patient to take Cobenfy on an empty stomach, either 1 hour before or 2 hours after a meal. Food will decrease the absorption of trospium and can lead to increased procholinergic adverse events from xanomeline. With half-lives of 5 hours for xanomeline and 6 hours for trospium, Cobenfy is prescribed twice a day, commonly upon awakening and at bedtime, to maximize adherence.</p><p class="pb-2">Before starting Cobenfy, liver function tests and a bilirubin level should be checked, as well as baseline heart rate. These should be monitored during treatment as clinically indicated. Prior to prescribing Cobenfy, the entire PI should be read and understood.</p><p class="pb-2"><strong>The Pipeline</strong></p><p class="pb-2">Cobenfy is the first in a novel class of medications that provide a muscarinic cholinergic mechanism of action for the treatment of individuals with schizophrenia. Two other drug candidates with similar mechanisms have recently completed phase 2 clinical trials. Emraclidine, an M4-selective positive allosteric modulator, is being evaluated in 2 placebo-controlled phase 2 trials in schizophrenia, EMPOWER-1 and EMPOWER-2, as well as in a 52-week open-label safety extension study, EMPOWER-3; trial results are expected to be released in late 2024. NBI-1117568 is a highly selective M4 agonist for the potential treatment of adults with schizophrenia and was evaluated in a recently completed phase 2 study. If FDA approved, these 2 molecules will help us understand the role of M1 agonism in the treatment of adults with schizophrenia, as this property is unique to Cobenfy.</p><p class="pb-2"><strong>Concluding Thoughts</strong></p><p class="pb-2">The medication treatment of schizophrenia has finally diversified to a novel neurotransmitter system, the muscarinic cholinergic system, with the FDA approval of Cobenfy on September 26, 2024. Our clinical experience with Cobenfy over the next several years will educate us on how this mechanism compares with the traditional blockade of D2Rs. Prescribers should familiarize themselves with all aspects of Cobenfy before using it, as it is a novel mechanism with important properties that are very different from the D2R antagonists. It is exciting and refreshing that after 70 years of domination by D2R antagonists, we have a novel neurotransmitter target for the treatment of individuals with schizophrenia.<br/></p><p class="pb-2"><strong>Dr Miller </strong><em>is medical director of Brain Health in Exeter, New Hampshire; editor in chief of </em>Psychiatric Times<em>; staff psychiatrist at Seacoast Mental Health Center, Exeter; and consulting psychiatrist at the Insight Meditation Society in Barre, Massachusetts.</em></p><p class="pb-2"></p><p class="pb-2"><em>Dr Miller would like to disclose that he was on the Advisory Board for Karuna and is part of the Speakers’ Bureau for Bristol Myers Squibb.</em></p><p class="pb-2"><strong>References</strong></p><p class="pb-2">1. Brannan SK, Sawchak S, Miller AC, et al. <a rel="nofollow noreferrer noopener" target="_blank" href="https://www.nejm.org/doi/full/10.1056/NEJMoa2017015">Muscarinic cholinergic receptor agonist and peripheral antagonist for schizophrenia.</a> <em>N Engl J Med</em>. 2021;25;384(8):717-726.</p><p class="pb-2">2. Kaul I, Sawchak S, Correll CU, et al. <a rel="nofollow noreferrer noopener" target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/38104575/">Efficacy and safety of the muscarinic receptor agonist KarXT (xanomeline-trospium) in schizophrenia (EMERGENT-2) in the USA: results from a randomised, double-blind, placebo-controlled, flexible-dose phase 3 trial.</a> <em>Lancet</em>. 2024;13;403(10422):160-170.</p><p class="pb-2">3. Kaul I, Sawchak S, Walling DP, et al. <a rel="nofollow noreferrer noopener" target="_blank" href="https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2818047">Efficacy and safety of xanomeline-trospium chloride in schizophrenia: a randomized clinical trial.</a> <em>JAMA Psychiatry.</em> 2024;81(8):749-756.</p><p class="pb-2">4. An extension study to assess long-term safety, tolerability, and efficacy of KarXT in adult patients with schizophrenia (EMERGENT-4). ClinicalTrials.gov. Updated November 29, 2023. Accessed October 14, 2024. <a rel="nofollow noreferrer noopener" target="_blank" href="https://clinicaltrials.gov/study/NCT04659174">https://clinicaltrials.gov/study/NCT04659174</a></p><p class="pb-2">5. An open-label study to assess the long-term safety, tolerability, and efficacy of KarXT in adult patients with schizophrenia (EMERGENT-5). ClinicalTrials.gov. Updated August 20, 2024. Accessed October 14, 2024. <a rel="nofollow noreferrer noopener" target="_blank" href="https://clinicaltrials.gov/study/NCT04820309">https://clinicaltrials.gov/study/NCT04820309</a></p><p class="pb-2">6. Cobenfy. Prescribing information. Bristol Myers Squibb; 2024. Accessed October 14, 2024. <a rel="nofollow noreferrer noopener" target="_blank" href="https://packageinserts.bms.com/pi/pi_cobenfy.pdf">https://packageinserts.bms.com/pi/pi_cobenfy.pdf</a></p><p class="pb-2">7. Mosolov SN, Yaltonskaya PA. <a rel="nofollow noreferrer noopener" target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/35046851/">Primary and secondary negative symptoms in schizophrenia.</a> <em>Front Psychiatry</em>. 2022;12:766692.</p><p class="pb-2">8. Miller JJ. <a target="_blank" href="https://www.psychiatrictimes.com/view/medication-pipeline-schizophrenia-and-ptsd">Medication pipeline: schizophrenia and PTSD.</a><em> Psychiatric Times</em>. 2024;41(1).</p><p class="pb-2"><br/></p></div></div><div class="flex items-center lg:w-3/4 mb-4 pb-12"><div class="flex sm:inline"><a target="_blank" class="mr-[5px] md:mr-2 p-[.56rem] border rounded-md bg-primary text-white" href="https://cdn.sanity.io/files/0vv8moc6/psychtimes/e10ffe3e89a70766afa190f65812cbcf1744c8eb.pdf/PSY1124_eZine.pdf">Download Issue PDF</a></div></div><div class="mb-6"><div class="jsx-19ede9f0a5a45918 py-4 relative bg-primary md:px-8 pl-2 -ml-6 xs:ml-0 w-screen xs:w-full mb-4 "><div class="jsx-19ede9f0a5a45918 px-4 sm:px-0"><div class="jsx-19ede9f0a5a45918 text-white text-2xl md:text-3xl pb-2 md:pb-1">Articles in this issue</div><hr class="jsx-19ede9f0a5a45918 -mr-2"/></div><div style="scroll-snap-type:none" class="jsx-19ede9f0a5a45918 flex items-start overflow-x-auto 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KarXT (Cobenfy) was approved by the US Food and Drug Administration (FDA) after a 15-year journey that started with a young scientist’s remarkable vision for developing a medication with the first new mechanism of action since 1954 to treat individuals with schizophrenia. The name KarXT defines the story: a small start-up company named Karuna Therapeutics, Inc, hypothesized that by combining 2 well-established molecules—xanomeline and trospium—brain circuits associated with schizophrenia could be modulated by a novel nondopaminergic mechanism to improve symptoms and have an entirely different pharmacology than all the other medications currently approved to treat schizophrenia that were developed over the past 70 years.\n\nThe Visionary\n\nAt age 27, Andrew Miller, who had just completed his chemical engineering doctorate, began to explore possible innovations for unmet needs in medicine. With no background in pharmacology or medicine, after much effort and investigation, Dr Miller became passionate about developing a new treatment for schizophrenia. Researching the existing literature on possible novel mechanisms of action, he identified an established model of treating cognitive and psychotic symptoms by agonizing 2 specific muscarinic cholinergic receptors (mAChRs) in the brain: M1 and M4. Back in the 1990s, Eli Lilly and Company studied xanomeline, a molecule that binds tightly to all 5 of the mAChRs and has significant agonism activity at the M1 and M4 receptors, as a possible treatment for cognitive function in Alzheimer disease. Significantly, xanomeline demonstrated improvement compared with placebo in cognitive function, and in an astounding and serendipitous finding, it also demonstrated improvements in psychotic symptoms in patients with Alzheimer disease. Subsequently, data from a study demonstrated improvement in psychosis and cognition in patients with schizophrenia. However, further development of xanomeline was abandoned due to the poor tolerability that is expected from a medication that agonizes the mAChRs in the peripheral nervous system, specifically nausea, vomiting, diarrhea, sweating, and salivation.\n\nThinking outside the metaphorical box, Dr Miller asked himself if adding an anticholinergic medication that could not cross the blood-brain barrier might just allow for the central M1 and M4 agonism while mitigating the peripheral mAChR adverse effects. Dr Miller and colleagues created a list of all existing candidate medication combinations, which numbered 7410. The first combination on that list was xanomeline and trospium—an anticholinergic medication the FDA approved in 2004 for overactive bladder. Dr Miller hypothesized that finding an optimal dosing combination of xanomeline and trospium could provide the central benefits for psychosis and cognition while minimizing the peripheral adverse events. The final obstacle in testing this hypothesis was a lack of financial resources, with only $4000 left in the bank account. At this point in the journey, Dr Miller was the only employee of Karuna, which was founded around the development of KarXT. He applied for funding from the Wellcome Trust, a philanthropic organization based in the United Kingdom, which awarded Karuna funding for the initial clinical trial with KarXT. With $5.5 million in hand, Dr Miller could assemble a team to investigate whether or not the xanomeline/trospium combination had a future in the treatment of individuals with schizophrenia.\n\nKarXT Clinical Development\n\nThe phase 2 clinical trial, named EMERGENT-1, was a 5-week double-blind placebo-controlled trial of KarXT in individuals with schizophrenia experiencing a significant relapse of symptoms, with an average Positive and Negative Syndrome Scale (PANSS) total score of 97, which places these patients in the “markedly ill” category. At the end of 5 weeks, the least square mean (LSM) improvement in total PANSS score, the primary outcome, in the KarXT group was 11.6 points greater than in the placebo group, with an effect size of 0.81.1 This robust outcome paved the way for 2 more identically designed phase 3 trials (EMERGENT-2 and -3), the findings of which demonstrated a similar improvement in the total PANSS score compared with placebo, as well as strong effect sizes (LSM improvements, 9.6 points and 8.4 points; effect sizes, 0.61 and 0.60, respectively).2,3 Finally, 2 open-label, 52-week phase 3 studies designed to further assess the long-term safety, tolerability, and efficacy of KarXT in adult patients with schizophrenia were completed. Data from those studies, EMERGENT-4 and -5, supported the findings of the 5-week studies.4,5\n\nNot an Antipsychotic\n\nSignificantly, in the FDA product insert (PI), Cobenfy is defined as being “indicated for the treatment of schizophrenia in adults.”6 Throughout the PI, it is never referred to as an antipsychotic medication. This is notable, as the FDA has described all other medications currently approved to treat schizophrenia, from chlorpromazine (Thorazine) in 1954 to lumateperone (Caplyta) in 2019, as antipsychotics. A common property of all these antipsychotic medications is antagonism or antagonism/partial agonism of the dopamine-2 receptor (D2R), which has been hypothesized to be the mechanism that decreases the positive symptoms of schizophrenia, such as auditory hallucinations and delusions.\n\nSchizophrenia has been well established as a syndrome with 3 primary symptom clusters—positive, negative, and cognitive symptoms. However, from 1954, when chlorpromazine became available in the United States, the treatment focus turned almost entirely to treatment of the positive symptoms because these responded to D2R blockade. Unfortunately, the antagonism of D2Rs in other parts of the brain comes at quite a cost, worsening the cognitive and negative symptoms (called secondary),7 muscle dystonia, akathisia, drug- induced parkinsonism, tardive dyskinesia, weight gain, sedation, prolactin elevation, neuroleptic malignant syndrome, and others. Cobenfy has not demonstrated any of these adverse events. It remains to be seen if Cobenfy improves cognitive and/or negative symptoms in schizophrenia. Additionally, Cobenfy has no boxed warnings from the FDA, and its adverse events, contraindications, warnings, and precautions documented in its PI are quite different from the antipsychotic medications we have been prescribing for the past 70 years. As a result, the prescriber has much to learn about this novel treatment option for individuals with schizophrenia. The interested reader can learn more about the putative mechanism of action of Cobenfy in reference 8.8\n\nAdverse Events, Warnings\n\nBoth xanomeline and trospium target the muscarinic cholinergic system, albeit oppositional to each other. Xanomeline has a strong affinity to all 5 mAChRs but significantly agonizes only 2: the M1 and the M4. Its action at these 2 mAChRs in the brain is hypothesized to decrease presynaptic dopamine release in the circuits relevant to schizophrenia while not affecting the circuits involved in motor function or hormones. In the peripheral nervous system, xanomeline demonstrates the expected adverse effects of nausea, vomiting, diarrhea, hypersalivation, and sweating. Trospium, which poorly crosses the blood-brain barrier, has minimal effects on the central nervous system but mitigates the procholinergic adverse effects of xanomeline in the peripheral nervous system through its anticholinergic activity. Not surprisingly, the common adverse events result from either procholinergic or anticholinergic activity, demonstrating the delicate balance that results from optimally dosing these 2 opposing mechanisms. Table 1 lists the common adverse events of Cobenfy.\n\n\n\nXanomeline is extensively metabolized by the liver, and as a result, Cobenfy is contraindicated in the presence of moderate to severe hepatic impairment. CYP2D6 also metabolizes it, and the dose may need to be decreased in the presence of potent CYP2D6 inhibitors. Trospium, on the other hand, is minimally metabolized in the body, and approximately 90% of it is excreted unchanged in the urine. Hence Cobenfy is contraindicated in patients with urinary retention and is not recommended in patients with moderate to severe renal impairment. In these conditions, trospium serum levels are likely to increase, increasing the anticholinergic load. Table 2 lists the contraindications for Cobenfy.\n\n\n\nIt is important to know about the presence of any other medication, prescribed or over the counter, that has anticholinergic activity. Benztropine, diphenhydramine, tricyclic antidepressants, clozapine, olanzapine, quetiapine, and chlorpromazine are some of the common medications our patients may be taking that have significant anticholinergic effects. Patients should be warned about the signs and symptoms of increased anticholinergic load.\n\nIt is crucial to instruct the patient to take Cobenfy on an empty stomach, either 1 hour before or 2 hours after a meal. Food will decrease the absorption of trospium and can lead to increased procholinergic adverse events from xanomeline. With half-lives of 5 hours for xanomeline and 6 hours for trospium, Cobenfy is prescribed twice a day, commonly upon awakening and at bedtime, to maximize adherence.\n\nBefore starting Cobenfy, liver function tests and a bilirubin level should be checked, as well as baseline heart rate. These should be monitored during treatment as clinically indicated. Prior to prescribing Cobenfy, the entire PI should be read and understood.\n\nThe Pipeline\n\nCobenfy is the first in a novel class of medications that provide a muscarinic cholinergic mechanism of action for the treatment of individuals with schizophrenia. Two other drug candidates with similar mechanisms have recently completed phase 2 clinical trials. Emraclidine, an M4-selective positive allosteric modulator, is being evaluated in 2 placebo-controlled phase 2 trials in schizophrenia, EMPOWER-1 and EMPOWER-2, as well as in a 52-week open-label safety extension study, EMPOWER-3; trial results are expected to be released in late 2024. NBI-1117568 is a highly selective M4 agonist for the potential treatment of adults with schizophrenia and was evaluated in a recently completed phase 2 study. If FDA approved, these 2 molecules will help us understand the role of M1 agonism in the treatment of adults with schizophrenia, as this property is unique to Cobenfy.\n\nConcluding Thoughts\n\nThe medication treatment of schizophrenia has finally diversified to a novel neurotransmitter system, the muscarinic cholinergic system, with the FDA approval of Cobenfy on September 26, 2024. Our clinical experience with Cobenfy over the next several years will educate us on how this mechanism compares with the traditional blockade of D2Rs. Prescribers should familiarize themselves with all aspects of Cobenfy before using it, as it is a novel mechanism with important properties that are very different from the D2R antagonists. It is exciting and refreshing that after 70 years of domination by D2R antagonists, we have a novel neurotransmitter target for the treatment of individuals with schizophrenia.\n\n\nDr Miller is medical director of Brain Health in Exeter, New Hampshire; editor in chief of Psychiatric Times; staff psychiatrist at Seacoast Mental Health Center, Exeter; and consulting psychiatrist at the Insight Meditation Society in Barre, Massachusetts.\n\n\n\nDr Miller would like to disclose that he was on the Advisory Board for Karuna and is part of the Speakers’ Bureau for Bristol Myers Squibb.\n\nReferences\n\n1. Brannan SK, Sawchak S, Miller AC, et al. Muscarinic cholinergic receptor agonist and peripheral antagonist for schizophrenia. N Engl J Med. 2021;25;384(8):717-726.\n\n2. Kaul I, Sawchak S, Correll CU, et al. Efficacy and safety of the muscarinic receptor agonist KarXT (xanomeline-trospium) in schizophrenia (EMERGENT-2) in the USA: results from a randomised, double-blind, placebo-controlled, flexible-dose phase 3 trial. Lancet. 2024;13;403(10422):160-170.\n\n3. Kaul I, Sawchak S, Walling DP, et al. Efficacy and safety of xanomeline-trospium chloride in schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2024;81(8):749-756.\n\n4. An extension study to assess long-term safety, tolerability, and efficacy of KarXT in adult patients with schizophrenia (EMERGENT-4). ClinicalTrials.gov. Updated November 29, 2023. Accessed October 14, 2024. https://clinicaltrials.gov/study/NCT04659174\n\n5. An open-label study to assess the long-term safety, tolerability, and efficacy of KarXT in adult patients with schizophrenia (EMERGENT-5). ClinicalTrials.gov. Updated August 20, 2024. Accessed October 14, 2024. https://clinicaltrials.gov/study/NCT04820309\n\n6. Cobenfy. Prescribing information. Bristol Myers Squibb; 2024. Accessed October 14, 2024. https://packageinserts.bms.com/pi/pi_cobenfy.pdf\n\n7. Mosolov SN, Yaltonskaya PA. Primary and secondary negative symptoms in schizophrenia. Front Psychiatry. 2022;12:766692.\n\n8. Miller JJ. Medication pipeline: schizophrenia and PTSD. Psychiatric Times. 2024;41(1).\n\n\n","description":"The medication treatment of schizophrenia has finally diversified to a novel neurotransmitter system: the muscarinic cholinergic system.","author":[{"@type":"Person","name":"John J. 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","_key":"4197413fead0"},{"_type":"span","marks":["em"],"text":"is a child psychiatrist, family psychotherapist, and philosopher in Montreal, Quebec, Canada, where he is professor of psychiatry \u0026 addiction medicine at the University of Montreal. He is also clinical professor of psychiatry \u0026 behavioral health at The George Washington University and president of the World Association of Social Psychiatry (WASP). Dr Di Nicola has received numerous national and international awards, honorary professorships, and fellowships. Of note, Dr Di Nicola was elected a Fellow of the Canadian Academy of Health Sciences (FCAHS), given the Distinguished Service Award of the American Psychiatric Association (APA), and is a Fellow-Elect of the American College of Psychiatrists (FACPsych). His work straddles psychiatry and psychotherapy on one side and philosophy and poetry on the other. 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","published":"2024-11-25T15:00:00.000Z","authorMapping":{"authorType":"author","displayName":"Brent Masel, MD","_rev":"3gTsRSIZZOlR1rZ7y82DnJ","_type":"author","_updatedAt":"2024-11-18T20:08:37Z","url":{"_type":"slug","current":"brent-masel-md"},"_createdAt":"2024-11-18T20:08:37Z","_id":"4f85f6c3-1c1f-4540-a517-dde66a3e1fe9","biography":[{"style":"normal","_key":"74b05eba1a0f","markDefs":[],"children":[{"marks":["strong"],"text":"Dr Masel ","_key":"b30f39de80ba0","_type":"span"},{"marks":["em"],"text":"is the executive vice-president for Medical Affairs with the Centre for Neuroskills and is a clinical professor of neurology at the University of Texas Medical Branch in Galveston.","_key":"b30f39de80ba1","_type":"span"}],"_type":"block"}]},"factCheckAuthorMapping":null},{"published":"2024-11-25T14:23:35.801Z","authorMapping":{"url":{"current":"h-steven-moffic-md","_type":"slug"},"displayName":"H. 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He was chosen to receive the 2024 Abraham Halpern Humanitarian Award from the American Association for Social Psychiatry. Previously, he received the Administrative Award in 2016 from the American Psychiatric Association, the one-time designation of being a Hero of Public Psychiatry from the Speaker of the Assembly of the APA in 2002, and the Exemplary Psychiatrist Award from the National Alliance for the Mentally Ill in 1991. He is an advocate and activist for mental health issues related to climate instability, physician burnout, and xenophobia. He is now editing the final book in a 4-volume series on religions and psychiatry for Springer: Islamophobia, anti-Semitism, Christianity, and now"},{"text":" The Eastern Religions, and Spirituality","_key":"4a00caaa2c0a","_type":"span","marks":[]},{"_type":"span","marks":["em"],"text":". 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","url":{"current":"the-return-of-zorro-and-sorro","_type":"slug"},"thumbnail":{"_type":"mainImage","alt":"zorro","caption":"Wiktoria Matynia/AdobeStock","asset":{"_ref":"image-317211a7e0ed51803ab0360dfb465d04e0ea95a3-4164x2452-jpg","_type":"reference"}},"contentCategory":{"name":"Articles","_id":"8bdaa7fc-960a-4b57-b076-75fdce3741bb","_updatedAt":"2020-02-25T09:35:56Z","_createdAt":"2020-02-06T09:15:47Z","_rev":"snQqhhB4O8T5bi1viURsgs","_type":"contentCategory"},"_id":"f6e15b3b-4869-411e-8684-ec04adad65ab","title":"The Return of Zorro and Sorro"},{"title":"Multidisciplinary Inpatient Care for Medically Compromised Youth and Young Adults With Eating Disorders","summary":"In this CME article, learn more about a protocolized approach to the hospital management of pediatric patients with severe malnutrition related to eating disorders, including the utilization of a multidisciplinary care team and structured psychoeducation materials for families.","thumbnail":{"alt":"eating disorders","caption":"Wanlee/AdobeStock","asset":{"_ref":"image-75e054327354fd399f1c1b0d16066577da5800d1-5000x3500-jpg","_type":"reference"},"_type":"mainImage"},"authorMapping":{"displayName":"Jessica M. Pierce, MD, MSc","_createdAt":"2024-11-22T14:13:08Z","_id":"3fa09261-2624-4db8-beda-31f80992ff4b","url":{"_type":"slug","current":"jessica-m-pierce-md-msc"},"authorType":"author","_type":"author","biography":[{"_type":"block","style":"normal","_key":"977b8bc0d21e","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Dr Pierce ","_key":"262f7acc2f3f0"},{"_type":"span","marks":["em"],"text":"is the medical director of the Pediatric Consultation-Liaison Psychiatry Service and the child and adolescent psychiatry hospital education lead at the C.S. Mott Children’s Hospital, University of Michigan Hospital Systems. 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KarXT (Cobenfy) was approved by the US Food and Drug Administration (FDA) after a 15-year journey that started with a young scientist’s remarkable vision for developing a medication with the first new mechanism of action since 1954 to treat individuals with schizophrenia. The name KarXT defines the story: a small start-up company named Karuna Therapeutics, Inc, hypothesized that by combining 2 well-established molecules—xanomeline and trospium—brain circuits associated with schizophrenia could be modulated by a novel nondopaminergic mechanism to improve symptoms and have an entirely different pharmacology than all the other medications currently approved to treat schizophrenia that were developed over the past 70 years.","_key":"2324ff57db30"}],"_type":"block","style":"normal","_key":"48544abe5f72","upload_doc":null},{"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"text":"The Visionary","_key":"1570d908a5750","_type":"span","marks":["strong"]}],"_type":"block","style":"normal","_key":"ebc371cb72fd","upload_doc":null},{"upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"At age 27, Andrew Miller, who had just completed his chemical engineering doctorate, began to explore possible innovations for unmet needs in medicine. With no background in pharmacology or medicine, after much effort and investigation, Dr Miller became passionate about developing a new treatment for schizophrenia. Researching the existing literature on possible novel mechanisms of action, he identified an established model of treating cognitive and psychotic symptoms by agonizing 2 specific muscarinic cholinergic receptors (mAChRs) in the brain: M1 and M4. Back in the 1990s, Eli Lilly and Company studied xanomeline, a molecule that binds tightly to all 5 of the mAChRs and has significant agonism activity at the M1 and M4 receptors, as a possible treatment for cognitive function in Alzheimer disease. Significantly, xanomeline demonstrated improvement compared with placebo in cognitive function, and in an astounding and serendipitous finding, it also demonstrated improvements in psychotic symptoms in patients with Alzheimer disease. Subsequently, data from a study demonstrated improvement in psychosis and cognition in patients with schizophrenia. However, further development of xanomeline was abandoned due to the poor tolerability that is expected from a medication that agonizes the mAChRs in the peripheral nervous system, specifically nausea, vomiting, diarrhea, sweating, and salivation.","_key":"0d95956b7ca60"}],"_type":"block","style":"normal","_key":"56eb1cc39b5c"},{"markDefs":[],"children":[{"text":"Thinking outside the metaphorical box, Dr Miller asked himself if adding an anticholinergic medication that could not cross the blood-brain barrier might just allow for the central M1 and M4 agonism while mitigating the peripheral mAChR adverse effects. Dr Miller and colleagues created a list of all existing candidate medication combinations, which numbered 7410. The first combination on that list was xanomeline and trospium—an anticholinergic medication the FDA approved in 2004 for overactive bladder. Dr Miller hypothesized that finding an optimal dosing combination of xanomeline and trospium could provide the central benefits for psychosis and cognition while minimizing the peripheral adverse events. The final obstacle in testing this hypothesis was a lack of financial resources, with only $4000 left in the bank account. At this point in the journey, Dr Miller was the only employee of Karuna, which was founded around the development of KarXT. He applied for funding from the Wellcome Trust, a philanthropic organization based in the United Kingdom, which awarded Karuna funding for the initial clinical trial with KarXT. With $5.5 million in hand, Dr Miller could assemble a team to investigate whether or not the xanomeline/trospium combination had a future in the treatment of individuals with schizophrenia.","_key":"ed5a6a468e560","_type":"span","marks":[]}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"c9e779451b41"},{"children":[{"_type":"span","marks":["strong"],"text":"KarXT Clinical Development","_key":"320c2f9baf250"}],"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"4d7974fdaa73","markDefs":[]},{"_key":"b01d0137fbcc","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"The phase 2 clinical trial, named EMERGENT-1, was a 5-week double-blind placebo-controlled trial of KarXT in individuals with schizophrenia experiencing a significant relapse of symptoms, with an average Positive and Negative Syndrome Scale (PANSS) total score of 97, which places these patients in the “markedly ill” category. At the end of 5 weeks, the least square mean (LSM) improvement in total PANSS score, the primary outcome, in the KarXT group was 11.6 points greater than in the placebo group, with an effect size of 0.81.","_key":"c65ebfc1d0d90"},{"_type":"span","marks":["superscript"],"text":"1 ","_key":"9d7bca75dd6b"},{"_type":"span","marks":[],"text":"This robust outcome paved the way for 2 more identically designed phase 3 trials (EMERGENT-2 and -3), the findings of which demonstrated a similar improvement in the total PANSS score compared with placebo, as well as strong effect sizes (LSM improvements, 9.6 points and 8.4 points; effect sizes, 0.61 and 0.60, respectively).","_key":"bce7ed37ab6d"},{"_type":"span","marks":["superscript"],"text":"2,3","_key":"a74c806f7f08"},{"marks":[],"text":" Finally, 2 open-label, 52-week phase 3 studies designed to further assess the long-term safety, tolerability, and efficacy of KarXT in adult patients with schizophrenia were completed. Data from those studies, EMERGENT-4 and -5, supported the findings of the 5-week studies.","_key":"497e4976e003","_type":"span"},{"_type":"span","marks":["superscript"],"text":"4,5","_key":"2d1c1312d2a4"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"2dd49e8b1fc0","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Not an Antipsychotic","_key":"abc7560b1b350"}],"upload_doc":null,"uploadAudio":null,"medias":null},{"_type":"block","style":"normal","_key":"2970e2991a81","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Significantly, in the FDA product insert (PI), Cobenfy is defined as being “indicated for the treatment of schizophrenia in adults.”","_key":"f1e51ebf4f090"},{"_key":"bcb7559f53dd","_type":"span","marks":["superscript"],"text":"6"},{"_type":"span","marks":[],"text":" Throughout the PI, it is never referred to as an antipsychotic medication. This is notable, as the FDA has described all other medications currently approved to treat schizophrenia, from chlorpromazine (Thorazine) in 1954 to lumateperone (Caplyta) in 2019, as antipsychotics. A common property of all these antipsychotic medications is antagonism or antagonism/partial agonism of the dopamine-2 receptor (D2R), which has been hypothesized to be the mechanism that decreases the positive symptoms of schizophrenia, such as auditory hallucinations and delusions.","_key":"9c26f867690b"}]},{"style":"normal","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"1923035f4778","markDefs":[{"nofollow":true,"blank":true,"_type":"link","href":"https://www.psychiatrictimes.com/view/medication-pipeline-schizophrenia-and-ptsd","_key":"5f62ae5fa389"}],"children":[{"_type":"span","marks":[],"text":"Schizophrenia has been well established as a syndrome with 3 primary symptom clusters—positive, negative, and cognitive symptoms. However, from 1954, when chlorpromazine became available in the United States, the treatment focus turned almost entirely to treatment of the positive symptoms because these responded to D2R blockade. Unfortunately, the antagonism of D2Rs in other parts of the brain comes at quite a cost, worsening the cognitive and negative symptoms (called secondary),","_key":"9557d6ae08350"},{"_type":"span","marks":["superscript"],"text":"7","_key":"ff18a76de960"},{"_type":"span","marks":[],"text":" muscle dystonia, akathisia, drug- induced parkinsonism, tardive dyskinesia, weight gain, sedation, prolactin elevation, neuroleptic malignant syndrome, and others. Cobenfy has not demonstrated any of these adverse events. It remains to be seen if Cobenfy improves cognitive and/or negative symptoms in schizophrenia. Additionally, Cobenfy has no boxed warnings from the FDA, and its adverse events, contraindications, warnings, and precautions documented in its PI are quite different from the antipsychotic medications we have been prescribing for the past 70 years. As a result, the prescriber has much to learn about this novel treatment option for individuals with schizophrenia. The interested reader can learn more about the putative mechanism of action of Cobenfy in ","_key":"7b2cb6614b94"},{"_key":"3ab02daadccb","_type":"span","marks":["5f62ae5fa389"],"text":"reference 8"},{"_type":"span","marks":[],"text":".","_key":"f660df0dff5d"},{"marks":["superscript"],"text":"8","_key":"97a1f9417b89","_type":"span"}],"_type":"block"},{"markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":["strong"],"text":"Adverse Events, Warnings","_key":"a8241f80c94c0"}],"_type":"block","style":"normal","_key":"16e913c4cc67"},{"children":[{"marks":[],"text":"Both xanomeline and trospium target the muscarinic cholinergic system, albeit oppositional to each other. Xanomeline has a strong affinity to all 5 mAChRs but significantly agonizes only 2: the M1 and the M4. Its action at these 2 mAChRs in the brain is hypothesized to decrease presynaptic dopamine release in the circuits relevant to schizophrenia while not affecting the circuits involved in motor function or hormones. In the peripheral nervous system, xanomeline demonstrates the expected adverse effects of nausea, vomiting, diarrhea, hypersalivation, and sweating. Trospium, which poorly crosses the blood-brain barrier, has minimal effects on the central nervous system but mitigates the procholinergic adverse effects of xanomeline in the peripheral nervous system through its anticholinergic activity. Not surprisingly, the common adverse events result from either procholinergic or anticholinergic activity, demonstrating the delicate balance that results from optimally dosing these 2 opposing mechanisms. ","_key":"cdbe1d4741530","_type":"span"},{"marks":["strong","aa45d3edf823"],"text":"Table 1","_key":"9d0b15f5042c","_type":"span"},{"_key":"e1f0ce9aeeab","_type":"span","marks":[],"text":" lists the common adverse events of Cobenfy."}],"_type":"block","style":"normal","_key":"5488a7bba695","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[{"_type":"link","href":"https://www.psychiatrictimes.com/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2Fbfd7da2da86e0aee0aff179174f205eb06bdeaf8-250x638.png%3Ffit%3Dcrop%26auto%3Dformat\u0026w=640\u0026q=75","_key":"aa45d3edf823","nofollow":true,"blank":true}]},{"disableTextWrap":false,"alignment":"right","_type":"figure","imgcaption":[{"_type":"block","style":"normal","_key":"497ba5e70359","markDefs":[],"children":[{"_key":"7d1c8d8a9d480","_type":"span","marks":["strong"],"text":"Table 1. "},{"marks":[],"text":"Common Adverse Reactions to Cobenfy","_key":"f29624ae05cb","_type":"span"},{"_type":"span","marks":["superscript"],"text":"6","_key":"8cb7e5d62b41"}]}],"disableLightBox":true,"_key":"1a580b34b226","asset":{"_type":"reference","_ref":"image-bfd7da2da86e0aee0aff179174f205eb06bdeaf8-250x638-png"},"blank":true,"alt":"TABLE 1. Common Adverse Reactions to Cobenfy","widthP":49,"upload_doc":null,"uploadAudio":null,"medias":null},{"upload_doc":null,"uploadAudio":null,"medias":null,"_key":"b389462117da","markDefs":[{"blank":true,"_type":"link","href":"https://www.psychiatrictimes.com/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2F57be0ef1d9c109ce14292559ec271dbb4bbcc809-254x488.png%3Ffit%3Dcrop%26auto%3Dformat\u0026w=640\u0026q=75","_key":"e6399295b187","nofollow":true}],"children":[{"_type":"span","marks":[],"text":"Xanomeline is extensively metabolized by the liver, and as a result, Cobenfy is contraindicated in the presence of moderate to severe hepatic impairment. CYP2D6 also metabolizes it, and the dose may need to be decreased in the presence of potent CYP2D6 inhibitors. Trospium, on the other hand, is minimally metabolized in the body, and approximately 90% of it is excreted unchanged in the urine. Hence Cobenfy is contraindicated in patients with urinary retention and is not recommended in patients with moderate to severe renal impairment. In these conditions, trospium serum levels are likely to increase, increasing the anticholinergic load. ","_key":"f699bdcd564e0"},{"_type":"span","marks":["strong","e6399295b187"],"text":"Table 2","_key":"7c7baf47c0d2"},{"text":" lists the contraindications for Cobenfy.","_key":"574d85a14dc7","_type":"span","marks":[]}],"_type":"block","style":"normal"},{"uploadAudio":null,"asset":{"_ref":"image-57be0ef1d9c109ce14292559ec271dbb4bbcc809-254x488-png","_type":"reference"},"blank":true,"alt":"TABLE 2. Contraindications of Cobenfy","upload_doc":null,"_type":"figure","imgcaption":[{"_type":"block","style":"normal","_key":"1a1bc4a68257","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Table 2. ","_key":"8341e997dc010"},{"_type":"span","marks":[],"text":"Contraindications of Cobenfy","_key":"b6619df40431"},{"_type":"span","marks":["superscript"],"text":"6","_key":"e647008ac7f0"}]}],"disableLightBox":true,"medias":null,"alignment":"right","disableTextWrap":false,"widthP":50,"_key":"1f55d4144761"},{"_key":"2352a5054c22","markDefs":[],"children":[{"_type":"span","marks":[],"text":"It is important to know about the presence of any other medication, prescribed or over the counter, that has anticholinergic activity. Benztropine, diphenhydramine, tricyclic antidepressants, clozapine, olanzapine, quetiapine, and chlorpromazine are some of the common medications our patients may be taking that have significant anticholinergic effects. Patients should be warned about the signs and symptoms of increased anticholinergic load.","_key":"c886ce98e9cf0"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal"},{"_key":"96218392221f","markDefs":[],"children":[{"text":"It is crucial to instruct the patient to take Cobenfy on an empty stomach, either 1 hour before or 2 hours after a meal. Food will decrease the absorption of trospium and can lead to increased procholinergic adverse events from xanomeline. With half-lives of 5 hours for xanomeline and 6 hours for trospium, Cobenfy is prescribed twice a day, commonly upon awakening and at bedtime, to maximize adherence.","_key":"160f03a931000","_type":"span","marks":[]}],"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null,"medias":null},{"markDefs":[],"children":[{"_key":"516e3b764e700","_type":"span","marks":[],"text":"Before starting Cobenfy, liver function tests and a bilirubin level should be checked, as well as baseline heart rate. These should be monitored during treatment as clinically indicated. Prior to prescribing Cobenfy, the entire PI should be read and understood."}],"_type":"block","style":"normal","_key":"f9e24cf9577d","upload_doc":null,"uploadAudio":null,"medias":null},{"_key":"3b3a2d629788","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"The Pipeline","_key":"e5421f17a0a30"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal"},{"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_key":"ac088838001e0","_type":"span","marks":[],"text":"Cobenfy is the first in a novel class of medications that provide a muscarinic cholinergic mechanism of action for the treatment of individuals with schizophrenia. Two other drug candidates with similar mechanisms have recently completed phase 2 clinical trials. Emraclidine, an M4-selective positive allosteric modulator, is being evaluated in 2 placebo-controlled phase 2 trials in schizophrenia, EMPOWER-1 and EMPOWER-2, as well as in a 52-week open-label safety extension study, EMPOWER-3; trial results are expected to be released in late 2024. NBI-1117568 is a highly selective M4 agonist for the potential treatment of adults with schizophrenia and was evaluated in a recently completed phase 2 study. If FDA approved, these 2 molecules will help us understand the role of M1 agonism in the treatment of adults with schizophrenia, as this property is unique to Cobenfy."}],"_type":"block","style":"normal","_key":"01f78e392d51","upload_doc":null},{"medias":null,"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Concluding Thoughts","_key":"e353958bbec20"}],"_type":"block","style":"normal","_key":"a8922d68bb7f","upload_doc":null,"uploadAudio":null},{"_type":"block","style":"normal","_key":"9b1631d64744","markDefs":[],"children":[{"_type":"span","marks":[],"text":"The medication treatment of schizophrenia has finally diversified to a novel neurotransmitter system, the muscarinic cholinergic system, with the FDA approval of Cobenfy on September 26, 2024. Our clinical experience with Cobenfy over the next several years will educate us on how this mechanism compares with the traditional blockade of D2Rs. Prescribers should familiarize themselves with all aspects of Cobenfy before using it, as it is a novel mechanism with important properties that are very different from the D2R antagonists. It is exciting and refreshing that after 70 years of domination by D2R antagonists, we have a novel neurotransmitter target for the treatment of individuals with schizophrenia.\n","_key":"eb6894edbc2e0"}],"upload_doc":null,"uploadAudio":null,"medias":null},{"children":[{"_type":"span","marks":["strong"],"text":"Dr Miller ","_key":"762a2d16d5a90"},{"text":"is medical director of Brain Health in Exeter, New Hampshire; editor in chief of ","_key":"3ac807c2b296","_type":"span","marks":["em"]},{"_type":"span","marks":[],"text":"Psychiatric Times","_key":"be226e34ff65"},{"_type":"span","marks":["em"],"text":"; staff psychiatrist at Seacoast Mental Health Center, Exeter; and consulting psychiatrist at the Insight Meditation Society in Barre, Massachusetts.","_key":"fe9ba826b285"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"9ac20fc8d553","markDefs":[]},{"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"68af3e6211bf"}],"_type":"block","style":"normal","_key":"bc0305290b53","upload_doc":null},{"markDefs":[],"children":[{"marks":["em"],"text":"Dr Miller would like to disclose that he was on the Advisory Board for Karuna and is part of the Speakers’ Bureau for Bristol Myers Squibb.","_key":"ede6feb807640","_type":"span"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"a0aab41aac36"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"References","_key":"9a96b23c47ab0"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"4f2ad877f278"},{"medias":null,"_key":"339db4658d28","markDefs":[{"_key":"fb9aa80d05ea","nofollow":true,"blank":true,"_type":"link","href":"https://www.nejm.org/doi/full/10.1056/NEJMoa2017015"}],"children":[{"marks":[],"text":"1. Brannan SK, Sawchak S, Miller AC, et al. ","_key":"aa22ed54e2220","_type":"span"},{"_type":"span","marks":["fb9aa80d05ea"],"text":"Muscarinic cholinergic receptor agonist and peripheral antagonist for schizophrenia.","_key":"d2ee2968cf7e"},{"_type":"span","marks":[],"text":" ","_key":"121ba6ed9a3b"},{"_type":"span","marks":["em"],"text":"N Engl J Med","_key":"253f7d3fb816"},{"text":". 2021;25;384(8):717-726.","_key":"61bc02b81318","_type":"span","marks":[]}],"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null},{"_key":"72db80a47fd4","markDefs":[{"nofollow":true,"blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/38104575/","_key":"19549e777d7a"}],"children":[{"_type":"span","marks":[],"text":"2. Kaul I, Sawchak S, Correll CU, et al. 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Updated November 29, 2023. Accessed October 14, 2024. ","_key":"672b009c6b850"},{"_type":"span","marks":["314cb01a35c8"],"text":"https://clinicaltrials.gov/study/NCT04659174","_key":"941ef4de5eb7"}],"_type":"block","style":"normal","_key":"da3fba47c5d4","upload_doc":null,"uploadAudio":null,"medias":null},{"children":[{"_key":"5497ef887b410","_type":"span","marks":[],"text":"5. An open-label study to assess the long-term safety, tolerability, and efficacy of KarXT in adult patients with schizophrenia (EMERGENT-5). ClinicalTrials.gov. Updated August 20, 2024. Accessed October 14, 2024. 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41, Issue 11","published":"2024-11-04T13:00:00.000Z","_createdAt":"2024-11-01T15:39:33Z","identifier":{"_type":"slug","current":"vol-41-issue-11"},"_type":"publication"},"published":"2024-11-07T16:00:53.264Z","documentGroup":null,"contentGroup":null,"gptTakeaways":"• KarXT (Cobenfy) introduces a novel nondopaminergic mechanism for schizophrenia treatment, combining xanomeline and trospium to target muscarinic cholinergic receptors.\n\n• Clinical trials demonstrated KarXT's efficacy and safety, showing significant improvement in PANSS scores without traditional antipsychotic adverse effects.\n\n• Cobenfy is not classified as an antipsychotic, lacking dopamine-2 receptor antagonism, and may offer benefits for cognitive and negative symptoms.\n\n• Prescribers must familiarize themselves with Cobenfy's unique properties, as it represents a shift in schizophrenia treatment towards muscarinic cholinergic pathways.","_createdAt":"2024-11-07T15:32:17Z","authorMapping":[{"displayName":"John J. Miller, MD","_rev":"iETXi7W7pY87NNzCpcZa11","biography":[{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Dr Miller","_key":"1caa3e4a631c0"},{"text":" ","_key":"1caa3e4a631c1","_type":"span","marks":[]},{"marks":["em"],"text":"is Medical Director, Brain Health, Exeter, New Hampshire; Editor in Chief,","_key":"1caa3e4a631c2","_type":"span"},{"_type":"span","marks":[],"text":" Psychiatric Times","_key":"1caa3e4a631c3"},{"_key":"1caa3e4a631c4","_type":"span","marks":["em"],"text":"; Staff Psychiatrist, Seacoast Mental Health Center, Exeter; and Consulting Psychiatrist, Insight Meditation Society, Barre, Massachusetts."}],"_type":"block","style":"normal","_key":"b9bc238502dd"}],"profileImage":{"_type":"mainImage","asset":{"_ref":"image-a429e28c06070418331e927699954a278efa97c9-1500x2100-jpg","_type":"reference"}},"url":{"current":"john-j-miller-md","_type":"slug"},"_createdAt":"2020-02-21T11:23:21Z","_type":"author","_id":"pst_author_324713","_updatedAt":"2024-03-27T15:40:23Z"}],"gptSummary":"The FDA's approval of KarXT (Cobenfy) marks a significant advancement in schizophrenia treatment, introducing a novel nondopaminergic mechanism. Developed by Karuna Therapeutics, KarXT combines xanomeline and trospium to target muscarinic cholinergic receptors, potentially improving symptoms without the adverse effects associated with traditional antipsychotics. Clinical trials demonstrated its efficacy and safety, distinguishing it from dopamine-2 receptor antagonists. Cobenfy's approval signifies a shift in schizophrenia treatment, focusing on muscarinic cholinergic pathways. 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","contentCategory":{"_createdAt":"2020-02-06T09:15:47Z","_rev":"snQqhhB4O8T5bi1viURsgs","_type":"contentCategory","name":"Articles","_id":"8bdaa7fc-960a-4b57-b076-75fdce3741bb","_updatedAt":"2020-02-25T09:35:56Z"},"_updatedAt":"2024-11-21T00:10:23Z","published":"2024-11-20T23:59:05.227Z","factCheckAuthorMapping":null,"audioUrl":"https://s3.us-east-1.amazonaws.com/ai-generated-audios/www.psychiatrictimes.com/e8a20671-2e4b-432c-a163-db333de883e1_1732147820544.ddc76bdc-f4ae-42ed-b251-2050b82ef3fc.mp3","_createdAt":"2024-11-21T00:10:13Z","thumbnail":{"asset":{"_ref":"image-3b6eff396436e76ce42df225e14b01caf05d8245-7952x5304-jpg","_type":"reference"},"_type":"mainImage"},"body":[{"alignment":"left","_type":"figure","alt":"OlegKachura_AdobeStock FDA","crop":{"bottom":0,"_type":"sanity.imageCrop","right":0,"top":0,"left":0.1118881118881118},"disableLightBox":true,"imgcaption":[{"_key":"da73f48774f1","markDefs":[],"children":[{"marks":[],"text":"OlegKachura_AdobeStock","_key":"c9bd23b8519f0","_type":"span"}],"_type":"block","style":"normal"}],"disableTextWrap":false,"_key":"922870e09d73","widthP":25,"hotspot":{"_type":"sanity.imageHotspot","width":0.8881118881118882,"x":0.5559440559440559,"y":0.5,"height":1},"asset":{"_ref":"image-3b6eff396436e76ce42df225e14b01caf05d8245-7952x5304-jpg","_type":"reference"}},{"markDefs":[],"children":[{"marks":["strong"],"text":"BREAKING NEWS\n","_key":"12c91a93f88b","_type":"span"}],"_type":"block","style":"normal","_key":"859133f76f72"},{"children":[{"_type":"span","marks":[],"text":"In a joint meeting of the US Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee and Psychopharmacologic Drugs Advisory Committee, members decided the ","_key":"ae6598f4162b0"},{"_type":"span","marks":["d51488acb350"],"text":"clozapine REMS (Risk Evaluation and Mitigation Strategy) protocol ","_key":"7714705c0a03"},{"_type":"span","marks":[],"text":"was no longer necessary and may even be a barrier to access.","_key":"5ebf4208dabe"},{"text":"1","_key":"d0fdb52cc80d","_type":"span","marks":["superscript"]}],"_type":"block","style":"normal","_key":"ed2c039e87a8","markDefs":[{"blank":true,"_type":"link","href":"https://www.psychiatrictimes.com/view/drug-update-clozapine-rems-recertification","_key":"d51488acb350","nofollow":true}]},{"_type":"block","style":"normal","_key":"dae2d84002f1","markDefs":[{"blank":true,"_type":"link","href":"https://www.psychiatrictimes.com/view/rems-for-psychiatric-medications-the-good-the-bad-and-the-ugly","_key":"6b342660d9f3","nofollow":true}],"children":[{"_type":"span","marks":[],"text":"The joint panel voted 14 to 1 that the requirement to monitor, document, and verify absolute neutrophil count (ANC) results were unnecessary, essentially dismissing the clozapine ","_key":"2dc3376df99a0"},{"_key":"88180ccf5ec0","_type":"span","marks":["6b342660d9f3"],"text":"REMS."},{"_type":"span","marks":["superscript"],"text":"1","_key":"fef80c1fe67f"}]},{"markDefs":[],"children":[{"text":"Before the vote, the committees heard testimony and evidence from pharmaceutical representatives as well as leaders in the field—John Kane, MD, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, and Robert O. Cotes, MD, Emory University School of Medicine. Kane and Cotes discussed the clinical context and implications of clozapine for patient populations.","_key":"58adf704430f0","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"2","_key":"bbfdb38e51b7"}],"_type":"block","style":"normal","_key":"433d0c10b4ee"},{"markDefs":[],"children":[{"_key":"84deadf9c8cc0","_type":"span","marks":[],"text":"Kane noted that “Clozapine is a cornerstone in the treatment of schizophrenia,” detailing its impact on treatment resistant schizophrenia in general as well as its ability to improve functioning, reduce mortality, reduce risk of relapse, among other clinical features."},{"text":"2","_key":"12827f71f7b7","_type":"span","marks":["superscript"]},{"_type":"span","marks":[],"text":" Kane also described the delays in obtaining clozapine, adding that the US lags behind in its use as compared to other countries.","_key":"be42b1dfc088"}],"_type":"block","style":"normal","_key":"6bd7ddc663c8"},{"_type":"block","style":"normal","_key":"aeafb3a8adcf","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Kane specifically addressed the risk of clozapine-induced neutropenia, which has been the foundation for the REMS protocol. He explained that the most serious cases occur within the first 18 weeks and that the risk decreases over time, becoming almost negligible after 2 years. “Long-term risk excess is small compared with advantages of clozapine in outcomes, including life expectancy,” he reported. ”Relaxing long-term monitoring could favor the advantages of clozapine use, without incurring risk of neutropenia.”","_key":"18e22a4b3fd30"},{"_type":"span","marks":["superscript"],"text":"2","_key":"7b77547d7ad1"}]},{"_key":"2d2f1b8ac65e","markDefs":[],"children":[{"_key":"c565c799b74a0","_type":"span","marks":[],"text":"Meanwhile, Cotes addressed prescriber, patient, and caregiver concerns, including challenges working with some pharmacies in submitting information. He discussed the results of a study that found 60% of clinicians prescribing clozapine said that “The safe use requirements have often caused delay in my patients receiving medication.” Cotes added that missed doses due to this bureaucracy can lead to the need for re-titration, psychological distress for patients, physical discomfort/withdrawal, symptom exacerbation, and can even lead to hospitalization."},{"_key":"17530ad78640","_type":"span","marks":["superscript"],"text":"2"}],"_type":"block","style":"normal"},{"children":[{"_type":"span","marks":[],"text":"In addition to expert testimony, patients, caregivers, clinicians, and advocates were given an opportunity to speak before the committee voted.","_key":"6a316006ab240"}],"_type":"block","style":"normal","_key":"2a455930a838","markDefs":[]},{"_type":"block","style":"normal","_key":"e6a2b1f72b3b","markDefs":[],"children":[{"_type":"span","marks":[],"text":"“The REMS program, while well-intentioned and -designed, does create a barrier to prescribers and patients using clozapine,” said Kathryn K. Erickson-Ridout, MD, a member of APA’s Council on Quality Care who testified on behalf of APA.3 Erickson-Ridout, who is also an inpatient psychiatrist and researcher for Kaiser Permanente, told the committee, ““I have been treating patients with treatment-resistant schizophrenia for 12 years and have seen the life-transforming benefit of this medication—controlling otherwise treatment-resistant psychotic symptoms and providing cognitive clarity.” ","_key":"51e90a4d955f0"}]},{"children":[{"marks":[],"text":"She added the disruptions in care resulted from the REMS protocol can lead to “disastrous results.”","_key":"aa3cc47443430","_type":"span"}],"_type":"block","style":"normal","_key":"cdb1d8cd1e2d","markDefs":[]},{"children":[{"_type":"span","marks":[],"text":"Similarly, epidemiologist and panelist Sascha Dublin, MD, PhD, emphasized the need for monitoring and support without “a punitive and technocratic approach.”","_key":"25820974114e0"},{"_type":"span","marks":["superscript"],"text":"3","_key":"3c7ed08f4587"}],"_type":"block","style":"normal","_key":"27d6c40b2c46","markDefs":[]},{"children":[{"text":"“I do not believe that the REMS’ approach to documenting and enforcing is serving the health of the patients or the needs of the community,” she said.","_key":"4a3dfec9d2bf0","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"0b6c6a7ff083","markDefs":[]},{"markDefs":[],"children":[{"text":"Although the committee overwhelmingly decided the REMS was no longer appropriate, Walter Dunn, MD, PhD disagreed. Dunn, Health Sciences Assistant Clinical Professor in the department of psychiatry at UCLA David Geffen School of Medicine, director of the Mood Disorders Clinic at West Los Angeles Veterans Affairs Medical Center, preferred monitoring when the risk was the greatest—during the first 18 weeks—instead of completely getting rid of the REMS. He did, however, suggest a more streamlined program without ANC levels.","_key":"7fee48f1814e0","_type":"span","marks":[]},{"_key":"acfaadd1cdfd","_type":"span","marks":["superscript"],"text":"1"}],"_type":"block","style":"normal","_key":"5366de8a504a"},{"markDefs":[{"href":"https://www.psychiatrictimes.com/view/clozapine-rems-regulatory-discrimination-against-psychiatrists","_key":"5a7bf474edb0","nofollow":true,"blank":true,"_type":"link"}],"children":[{"_type":"span","marks":[],"text":"In a recent article for ","_key":"80b8b91534900"},{"text":"Psychiatric Times","_key":"80b8b91534901","_type":"span","marks":["em","5a7bf474edb0"]},{"_type":"span","marks":[],"text":", Gilbert Honigfeld, PhD, detailed the onerous process and the delays in treatment that result from REMS, even referring to it as a discriminatory practice against psychiatric clinicians.","_key":"80b8b91534902"},{"marks":["superscript"],"text":"4","_key":"880f2a14f95c","_type":"span"}],"_type":"block","style":"normal","_key":"8ca00f559ec5"},{"style":"normal","_key":"376432600a8e","markDefs":[],"children":[{"_type":"span","marks":[],"text":"“From the point of view of professional equity alone then, clozapine REMS is clearly discriminatory and should be eliminated immediately,” he wrote.","_key":"8abb61a4f7330"},{"_type":"span","marks":["superscript"],"text":"4","_key":"c06c83f1b504"},{"_key":"9bd3b0140e8e","_type":"span","marks":[],"text":" “Psychiatrists are physicians first, specialists second. They are as capable of monitoring the health and well-being of their patients as physicians in all other medical specialties. No medicine is free of significant adversity, and clozapine’s low overall rate of fatal outcomes turns out to be quite comparable to other antipsychotic medicines, if not better.”"}],"_type":"block"},{"_type":"block","style":"normal","_key":"35ddcc57aa61","markDefs":[],"children":[{"_type":"span","marks":[],"text":"“As well intended as it might once have seemed, the federal REMS program is now one of the primary obstacles standing in the way of patients receiving their medicine on time,” he added.","_key":"4bd19ff897f00"},{"_type":"span","marks":["superscript"],"text":"4","_key":"2cd84761ed9c"},{"_type":"span","marks":[],"text":" “It is a major factor limiting access to clozapine for individuals with serious mental illnesses whose very lives might well depend on it. Solution? Eliminate FDA’s clozapine REMS program and allow psychiatrists to practice medicine just like their peers in all other medical specialties.”","_key":"ad08774ba85f"}]},{"markDefs":[],"children":[{"_key":"a2cacd160e480","_type":"span","marks":["em"],"text":"What do you think of this decision and how will it impact your prescribing strategy and patients? Share your thoughts with us via PTEditor@mmhgroup.com."}],"_type":"block","style":"normal","_key":"aaf11f441454"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"References","_key":"e5f5da6c57440"}],"_type":"block","style":"normal","_key":"208fc07548d6"},{"children":[{"_type":"span","marks":[],"text":"1. Sutter S. Clozapine REMS A Barrier To Treatment And Unnecessary For Safe Use, US FDA Adcomms Say. ","_key":"f2fa6ed975360"},{"_type":"span","marks":["em"],"text":"The Pink Sheet. ","_key":"f2fa6ed975361"},{"_type":"span","marks":[],"text":"November 20, 2024. Accessed November 20, 2024. ","_key":"f2fa6ed975362"},{"_type":"span","marks":["1fc3d61f6408"],"text":"https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/clozapine-rems-a-barrier-to-treatment-and-unnecessary-for-safe-use-us-fda-adcomms-say-KDK6ICJKNBHPTBGVFFL3C6ME7U/","_key":"f2fa6ed975363"}],"_type":"block","style":"normal","_key":"d6c3935bc857","markDefs":[{"href":"https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/clozapine-rems-a-barrier-to-treatment-and-unnecessary-for-safe-use-us-fda-adcomms-say-KDK6ICJKNBHPTBGVFFL3C6ME7U/","_key":"1fc3d61f6408","_type":"link"}]},{"_type":"block","style":"normal","_key":"23601345cdbd","markDefs":[{"_type":"link","href":"https://www.fda.gov/media/183655/download","_key":"fcf608efde8c"}],"children":[{"_type":"span","marks":[],"text":"2. FDA Advisory Committee Meeting Clozapine Risk Evaluation and Mitigation Strategy. November 19, 2024. Accessed November 20, 2024. ","_key":"774434e85b970"},{"_type":"span","marks":["fcf608efde8c"],"text":"https://www.fda.gov/media/183655/download","_key":"774434e85b971"}]},{"markDefs":[{"_type":"link","href":"https://alert.psychnews.org/2024/11/fda-panel-votes-14-1-against-clozapine.html","_key":"b897a4fa8213"}],"children":[{"_key":"037ce336590f0","_type":"span","marks":[],"text":"3. "},{"_type":"span","marks":["b897a4fa8213"],"text":"FDA Panel Votes 14-1 Against Clozapine REMS","_key":"037ce336590f1"},{"_type":"span","marks":[],"text":". APA News Alert. November 20, 2024. Accessed November 20, 2024. https://alert.psychnews.org/","_key":"037ce336590f2"}],"_type":"block","style":"normal","_key":"6578599842ea"},{"children":[{"_type":"span","marks":[],"text":"4. Honigfeld G. ","_key":"4e457ef1ed930"},{"_type":"span","marks":["b1e6be581e34"],"text":"Clozapine REMS: Regulatory Discrimination Against Psychiatrists? ","_key":"3280d930d343"},{"_type":"span","marks":["em"],"text":"Psychiatric Times","_key":"fb1bf8751661"},{"_type":"span","marks":[],"text":". October 3, 2024. Accessed November 20, 2024. https://www.psychiatrictimes.com/view/clozapine-rems-regulatory-discrimination-against-psychiatrists","_key":"2e55da0cbbf0"}],"_type":"block","style":"normal","_key":"ec4cea3d91a5","markDefs":[{"_key":"b1e6be581e34","nofollow":true,"blank":true,"_type":"link","href":"https://www.psychiatrictimes.com/view/clozapine-rems-regulatory-discrimination-against-psychiatrists"}]}],"authors":[{"displayName":"Heidi Anne Duerr, MPH","url":"heidi-anne-duerr-mph"}],"documentGroup":null,"documentGroupMapping":null,"drugMentions":"{\"drug_mentions\": [\"clozapine\"]}","_rev":"9UNt8aPfz3J9yPrHiMUtK1","gptTakeaways":"• The FDA advisory committees voted 14-1 to dismiss the clozapine REMS protocol, citing it as a barrier to access.\n\n• Experts emphasized clozapine's benefits for treatment-resistant schizophrenia and the challenges posed by REMS, including delays and care disruptions.\n\n• Dr. Walter Dunn suggested limited monitoring during high-risk periods, but the consensus was that REMS hinders timely access to clozapine.\n\n• The decision reflects concerns about professional equity and the need for psychiatrists to practice without unnecessary regulatory burdens.","title":"FDA Committees Vote to Dismiss Clozapine REMS","ExcludeFromPubMedXML":false,"url":"fda-committees-vote-to-dismiss-clozapine-rems","factCheckAuthors":null,"articleType":"News","authorMapping":[{"_updatedAt":"2022-11-04T04:02:22Z","url":{"current":"heidi-anne-duerr-mph","_type":"slug"},"displayName":"Heidi Anne Duerr, MPH","_createdAt":"2020-02-21T11:23:21Z","_rev":"XrZTRYYU2ruBFxkUazcNYZ","_type":"author","_id":"pst_author_322796","biography":[{"children":[{"_type":"span","marks":["em","superscript"],"text":" ","_key":"bde5e0065537"},{"_type":"span","marks":["em"],"text":" ","_key":"4f377fc862af"}],"_type":"block","style":"normal","_key":"edd659221a86","markDefs":[]}]}],"gptSummary":"The FDA's advisory committees have voted overwhelmingly to dismiss the clozapine REMS protocol, citing it as an unnecessary barrier to treatment. Experts, including Dr. John Kane and Dr. Robert O. Cotes, highlighted clozapine's benefits for treatment-resistant schizophrenia and the challenges posed by REMS, such as delays and disruptions in care. While some experts, like Dr. Walter Dunn, advocated for limited monitoring, the consensus was that the REMS program hinders timely access to clozapine, impacting patient outcomes and professional equity for psychiatrists.","is_visible":true,"taxonomyMapping":[{"_updatedAt":"2024-04-24T15:53:24Z","pixelTrackingCode":null,"_createdAt":"2024-04-24T15:53:24Z","name":"Drug 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","_id":"7eb76f59-ba6c-4cb6-a881-247af7838bfa","gptSummary":"Schizophrenia, a complex chronic mental health condition, affects 2.4 million American adults annually. Antipsychotics, evolving since the 1950s, are the standard treatment, available in oral and long-acting injectable (LAI) forms. LAIs, like aripiprazole lauroxil, improve adherence, reducing relapse and rehospitalization rates. Despite their benefits, stigma and misconceptions hinder their use. A team-based, patient-centric approach enhances treatment success, addressing barriers like financial concerns and patient fears. Shared decision-making empowers patients, fostering adherence and improving outcomes in schizophrenia management.","_updatedAt":"2024-11-15T15:03:57Z","gptTakeaways":"• Antipsychotics, including LAIs, are crucial for managing schizophrenia, improving adherence and reducing relapse and rehospitalization rates.\n\n• Stigma and misconceptions about LAIs persist, often viewed as treatments for severe cases, despite evidence supporting early use.\n\n• A team-based, patient-centric approach, involving all healthcare team members, enhances treatment success and addresses barriers.\n\n• Shared decision-making empowers patients, fostering adherence and improving outcomes in schizophrenia management.","factCheckAuthors":null,"documentGroup":null,"body":[{"widthP":50,"disableTextWrap":false,"_type":"figure","imgcaption":[{"_type":"block","style":"normal","_key":"0ff97ad5226e","markDefs":[],"children":[{"_type":"span","marks":[],"text":"tashatuvango/AdobeStock","_key":"d90c38fccec40"}]}],"disableLightBox":true,"_key":"43919653ccc6","asset":{"_ref":"image-4d0666c33abcebc4983e7f4b879ee0fc1eff754f-5733x3780-jpg","_type":"reference"},"alignment":"left","alt":"schizophrenia"},{"markDefs":[],"children":[{"_key":"8f9153848a720","_type":"span","marks":[],"text":"Schizophrenia is one of the most severe and complex chronic mental health conditions. In the US, an estimated 2.4 million American adults live with the disease in a given year."},{"_type":"span","marks":["superscript"],"text":"1","_key":"b38b15fe2403"},{"_type":"span","marks":[],"text":" As clinicians, we witness firsthand the challenges that individuals living with complex mental health conditions face. For many, this begins with receiving an accurate diagnosis and goes on to include a lifetime of assessing the long-term disease management options that work for them.","_key":"da0a700eb28e"}],"_type":"block","style":"normal","_key":"b24bfbff1a77"},{"markDefs":[],"children":[{"marks":[],"text":"","_key":"150e509d23ca0","_type":"span"}],"_type":"block","style":"normal","_key":"eb3d3045180e"},{"_type":"block","style":"normal","_key":"59815ee43391","markDefs":[],"children":[{"text":"Since their introduction in the 1950s, antipsychotics have undergone meaningful evolution,","_key":"2a5b30a7aa560","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"2","_key":"1be209281e9d"},{"text":" and today, they are the standard of care for the treatment of schizophrenia, helping to stabilize symptoms, reduce the risk of relapse, and contribute to patients’ overall wellness goals. Antipsychotics are available in both oral and long-acting injectable (LAI) formulations. The distinctions between different approved antipsychotics and their formulations, as well as appropriateness for a given patient, are important considerations in treatment decision-making.","_key":"bdf727874856","_type":"span","marks":[]}]},{"markDefs":[],"children":[{"text":"","_key":"53322f2278800","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"2d18c1c25626"},{"style":"normal","_key":"6733b52214ce","markDefs":[],"children":[{"_key":"bf943a530ede0","_type":"span","marks":["strong"],"text":"The Role of LAIs"}],"_type":"block"},{"_key":"c3928b1e12f3","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Adherence is critical in the management of schizophrenia.","_key":"9cc95a8ecf020"},{"_type":"span","marks":["superscript"],"text":"3","_key":"082a187186ab"},{"_type":"span","marks":[],"text":" Research suggests correlations between inconsistency in medication utilization and exacerbated risk factors related to treatment effect, relapse, rehospitalization, and other downstream outcomes. While specific metrics for nonadherence vary, there is broad awareness that individuals living with schizophrenia commonly experience challenges related to their medication schedule. For example, a lack of insight into the disease, concerns about adverse effects, and challenges related to daily dosing requirements may impact individual adherence. In addition, external factors that may impact a patient’s ability to take their medication as prescribed may include age, socioeconomic status, and educational background.","_key":"de84fec1401c"},{"_key":"0add38cad32d","_type":"span","marks":["superscript"],"text":"3"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"d7355378c790","markDefs":[],"children":[{"text":"","_key":"5172ed5708710","_type":"span","marks":[]}]},{"_type":"block","style":"normal","_key":"221f581b796c","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Health care providers who become aware that a patient is having difficulty, for any reason, with taking their oral medication as prescribed may wish to consider an LAI, such as aripiprazole lauroxil (Aristada), as a treatment option. With dosing intervals ranging from 2 weeks to 6 months and directly administered in a health care setting by a qualified professional, LAIs may provide advantages over oral therapies,","_key":"9727e8fd6c950"},{"_type":"span","marks":["superscript"],"text":"4","_key":"92c83056adee"},{"text":" as related to questions of medication adherence. Specifically, patients, health care providers, and even loved ones serving as caregivers may find reassurance in the knowledge that dosing is consistent over a period of time. Moreover, alleviating the need for daily decision-making and recollection about a particular medication schedule may open the door to more conversation and exploration of additional wraparound services and support, including attention to self-care and counseling.","_key":"f19f805b028c","_type":"span","marks":[]}]},{"children":[{"text":"","_key":"033680c8c3c50","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"b82e5d718933","markDefs":[]},{"markDefs":[],"children":[{"marks":[],"text":"One study observed that treatment with an LAI reduced rates of hospital readmission by 29%, when compared with treatment with oral antipsychotic medications, with an even more dramatic outcome of 58% when measuring repeated readmissions.","_key":"be15c43f99800","_type":"span"},{"text":"5","_key":"cf966df2b47d","_type":"span","marks":["superscript"]},{"_type":"span","marks":[],"text":" Given the progressive and often cyclical nature of schizophrenia, as well as high personal and systemic costs, it is clinically important to think about tactics that may reduce circumstances that require recurrent hospitalization.","_key":"00c52cc0b11f"}],"_type":"block","style":"normal","_key":"32bc2872e99c"},{"style":"normal","_key":"da087a5bc86e","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"c7571ea211740"}],"_type":"block"},{"markDefs":[],"children":[{"marks":[],"text":"Nevertheless, despite data supporting LAIs in the treatment of schizophrenia, stigma and lack of information and awareness regarding their use persist. For example, injections are often viewed as a treatment for the most severe or late-stage cases despite research supporting their use early in the disease and as long-term, maintenance treatment. These misconceptions may prevent some providers and patients from selecting an LAI as a treatment option, especially early in disease.","_key":"0ac1b6fda7fd0","_type":"span"}],"_type":"block","style":"normal","_key":"e33c9fed0591"},{"children":[{"_type":"span","marks":[],"text":"","_key":"ed1abdf395530"}],"_type":"block","style":"normal","_key":"da1074bfc1e4","markDefs":[]},{"_type":"block","style":"normal","_key":"cac0d16d5fd9","markDefs":[],"children":[{"_type":"span","marks":[],"text":"In my experience, much of the hesitation with LAIs stems from clinicians' assumptions about patient preferences, including perceived fear of injections, or presumptions about insurance coverage or other monetary obstacles. I have found that employing a collaborative, team-based approach that includes all health care team members working in sync with the patient leads to greater success in addressing these concerns.","_key":"6275f6b2d1720"}]},{"style":"normal","_key":"463a5d08793b","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"60ba80e72c8f0"}],"_type":"block"},{"style":"normal","_key":"64ee65de6882","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Treatment Conversations Through a Team-Based Approach","_key":"3f97f8f429aa0"}],"_type":"block"},{"markDefs":[],"children":[{"_key":"c93df400fb350","_type":"span","marks":[],"text":"In our practice, we foster a collaborative care environment to address barriers to treatment with LAIs. When the entire care team plays a role in developing and executing a care plan, it builds trust and engagement. Shared decision-making that includes health care providers, patients, and caregivers helps ensure alignment with desired goals."}],"_type":"block","style":"normal","_key":"5ab87804cff2"},{"markDefs":[],"children":[{"marks":[],"text":"","_key":"85f7b9ef76f40","_type":"span"}],"_type":"block","style":"normal","_key":"f76c8a1d79bb"},{"_type":"block","style":"normal","_key":"f6b029dc17af","markDefs":[],"children":[{"_type":"span","marks":[],"text":"We have found the following steps support open communication related to treatment choices and objectives:","_key":"5fed5d445fb50"}]},{"markDefs":[],"children":[{"_key":"b2cc19ee1c2d0","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal","_key":"95c91e11dc10"},{"children":[{"_type":"span","marks":["strong"],"text":"-Involve the whole team in decision-making. ","_key":"a6eb4020eb190"},{"_key":"a6eb4020eb191","_type":"span","marks":[],"text":"Psychiatrists, advanced practice providers (APPs), nurses, case managers, front-office staff, and pharmacists all add value, insights, and support along a patient’s treatment journey."}],"_type":"block","style":"normal","_key":"7579a491d083","markDefs":[]},{"_key":"d840e2a6f85e","markDefs":[],"children":[{"marks":[],"text":"","_key":"104d305cf75e0","_type":"span"}],"_type":"block","style":"normal"},{"_key":"d224487453a4","markDefs":[],"children":[{"_key":"66e90e91adca0","_type":"span","marks":[],"text":"For example, pharmacists can help address concerns about medication access by identifying patient assistance programs and prescription availability. Together, we can verify whether a patient's insurance covers the treatment and seek out vouchers or other types of aid when needed. In my experience, this sort of collaboration can help alleviate the practical worries faced by patients and their families."}],"_type":"block","style":"normal"},{"children":[{"text":"","_key":"78125c4143dc0","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"fd9761ffc179","markDefs":[]},{"style":"normal","_key":"0d4bee4722f2","markDefs":[],"children":[{"_key":"2cd269ec6ca90","_type":"span","marks":[],"text":"When a patient is due for an Aristada injection, we make sure we have the medicine in the office and are prepared to administer it. We are transparent about what will happen during the appointment, which conveys respect to facilitate a more positive experience."}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"15506a0167040"}],"_type":"block","style":"normal","_key":"fa7767fffd09"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"-Embrace a patient-centric mindset. ","_key":"f901961c9c6e0"},{"_type":"span","marks":[],"text":"Everyone who walks through our doors feels valued and important. We build trust. We look at patients as our clients, to whom we owe excellent service. It is our job to give them all the options. To that end, we introduce LAIs as an option as appropriate, even as early as the initial visit, emphasizing patient choice and considerations related to convenience and consistency in treatment.","_key":"f901961c9c6e1"}],"_type":"block","style":"normal","_key":"7e78b649d21f"},{"_key":"e1edff9f7b47","markDefs":[],"children":[{"marks":[],"text":"","_key":"43390f6051bc0","_type":"span"}],"_type":"block","style":"normal"},{"style":"normal","_key":"f51db07de328","markDefs":[],"children":[{"_type":"span","marks":[],"text":"If the idea of a needle produces anxiety, we show the patient the needle sizes and then walk them through every step, letting them know we support them. Focusing on the longer-term benefits can help manage fears. 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This case highlights the frequent overlap of trauma and psychosis, emphasizing the need for trauma-informed care. Trauma is often overlooked in psychosis assessments, leading to inadequate treatment. Implementing trauma-informed approaches and evidence-based PTSD treatments, such as trauma-focused CBTp, can improve outcomes. Clinicians should routinely assess trauma in psychosis patients and adapt interventions to address both trauma and psychosis symptoms effectively, supporting recovery and reducing distress.","issueGroup":{"_ref":"7d283d85-869a-4578-b7e0-00266f149eb6","_type":"reference"},"body":[{"_key":"ea3d94bb02c1","widthP":52,"disableLightBox":true,"_type":"figure","asset":{"_ref":"image-3baa097f1742d64c9afda10b2c6f7deda469f1dc-7280x4080-jpg","_type":"reference"},"disableTextWrap":false,"alt":"trauma","imgcaption":[{"markDefs":[],"children":[{"_key":"01fe0f8049d20","_type":"span","marks":[],"text":"necropos12/AdobeStock"}],"_type":"block","style":"normal","_key":"c7587d8ba6a0"}],"alignment":"left"},{"markDefs":[],"children":[{"_key":"3923afc8f8ae","_type":"span","marks":["strong"],"text":"Case Vignette "}],"_type":"block","style":"normal","_key":"9cfae10a87c3"},{"_type":"block","style":"normal","_key":"6f0a120a970f","markDefs":[],"children":[{"marks":[],"text":"“Sasha” is a 23-year-old nonbinary Asian American individual. Sasha is a survivor of childhood emotional and physical abuse by their parents. In addition, Sasha was physically assaulted when they were a freshman in college as they were walking back to their dorm late at night. Soon after this experience, they started having nightmares and flashbacks about the assault. They became easily startled and hypervigilant and no longer felt safe in lecture halls and on campus, which led them to drop out of college. Sasha also believes that strangers on the street intend to harm them physically, and they let Sasha know this by making eye contact with Sasha or by touching their faces. Sasha also reports seeing shadowy figures that seem threatening and hearing voices—both of their abusers from the past and strangers. These voices say degrading things about Sasha, which they interpret as a sign that there is a larger plot against them. Sasha no longer feels safe leaving the house or socializing, is disengaged from loved ones, is unable to return to college or work, and is currently on a leave of absence from their job at a daycare center. In the context of reduced sleep, concerns about financial stressors, and worsening voices, Sasha presents to the emergency department, where they disclose their voices, the shadowy figures, and fears that others in their neighborhood are threatening them. They are commenced on antipsychotic medication and are connected with their local early psychosis service for follow-up. ","_key":"ae86b87ed1ba","_type":"span"}]},{"_type":"block","style":"normal","_key":"19df16d351eb","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Trauma and Psychosis","_key":"2d2c4984cef80"}]},{"markDefs":[{"nofollow":true,"blank":true,"_type":"link","href":"https://www.psychiatrictimes.com/topics/ptsd","_key":"478472b25997"}],"children":[{"_type":"span","marks":[],"text":"Per the Substance Abuse and Mental Health Services Administration (SAMHSA), “Individual trauma results from an event, series of events, or set of circumstances that is experienced by an individual as physically or emotionally harmful or life threatening and that has lasting adverse effects on the individual’s functioning and mental, physical, social, emotional, or spiritual well-being.” ","_key":"f449939cd7920"},{"_type":"span","marks":["478472b25997"],"text":"Posttraumatic stress disorder","_key":"f67cd3fc6889"},{"_type":"span","marks":[],"text":" (PTSD) refers to a cluster of symptoms often experienced by individuals who have experienced trauma. Whether a person who has experienced a traumatic event will go on to qualify for a diagnosis of PTSD depends on the event, the person’s experience of the event, and the long-lasting adverse effects of the event.","_key":"a3b6e2739dbe"},{"_type":"span","marks":["superscript"],"text":"1","_key":"92582eb60ccd"}],"_type":"block","style":"normal","_key":"68f22e6675d4"},{"style":"normal","_key":"863374d0a5fa","markDefs":[],"children":[{"text":"Sasha’s presentation with comorbid symptoms of psychosis and PTSD is not unusual. Individuals experiencing psychosis often have also been exposed to traumatic life events,","_key":"ee6a2b1559200","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"2,3","_key":"a27c7b8ee84a"},{"_key":"dcb93fc61fa0","_type":"span","marks":[],"text":" with some estimates suggesting that all individuals with a psychotic disorder have experienced at least 1 traumatic event."},{"_type":"span","marks":["superscript"],"text":"2","_key":"99c0afb0ecfe"},{"_type":"span","marks":[],"text":" In addition, the experience of psychosis, as well as some aspects of mental health treatment including police involvement in admission, seclusion, and restraint, can also be traumatic.","_key":"dd679da3dd71"},{"_type":"span","marks":["superscript"],"text":"4","_key":"65573a220790"},{"_type":"span","marks":[],"text":" The rates of PTSD in those experiencing psychosis range from 10% to 30%, and approximately 40% of individuals with PTSD experience psychosis.","_key":"212019e0ea47"},{"_type":"span","marks":["superscript"],"text":"3,5-8","_key":"5097ee08e0cc"},{"_key":"360632143304","_type":"span","marks":[],"text":" Psychosis-related PTSD, or PTSD directly related to having a psychotic episode, varies from 14% to 47%."},{"marks":["superscript"],"text":"9","_key":"3ffe271492c2","_type":"span"},{"_type":"span","marks":[],"text":" Comorbid PTSD/psychosis is associated with increased health care use and worse clinical outcomes.","_key":"e02108a5ca10"},{"_type":"span","marks":["superscript"],"text":"8,10","_key":"797dc58322e8"},{"_type":"span","marks":[],"text":" Hence, when planning for effective care, it is important to assess for trauma and PTSD in anyone presenting with symptoms of psychosis.","_key":"69351212f915"}],"_type":"block"},{"style":"normal","_key":"ecb3ce78093d","markDefs":[],"children":[{"marks":["strong","em"],"text":"Clinical Pearl:","_key":"56654ffc90760","_type":"span"},{"marks":["strong"],"text":" ","_key":"8c35cc633a2d","_type":"span"},{"_key":"12f9523c581a","_type":"span","marks":[],"text":"Traumatic experiences are very common for those who report symptoms of psychosis. Trauma may be a result of early childhood experiences or later traumatic experiences linked to psychosis symptoms or treatment for psychosis. Psychosis symptoms can also occur in the context of PTSD and posttraumatic stress. "}],"_type":"block"},{"_key":"31d6921130a7","markDefs":[],"children":[{"_key":"2a2bedb339b7","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal"},{"children":[{"_type":"span","marks":["strong"],"text":"Assessment of Trauma in Individuals Experiencing Psychosis","_key":"d92720c7ab3b0"}],"_type":"block","style":"normal","_key":"68cd91cd5237","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Trauma is often overlooked in individuals with psychosis, resulting in an inadequate assessment of traumatic or adverse life events and, therefore, limited access to gold standard, evidence-based trauma treatments. Assessing for trauma should occur routinely, and access to these treatments should be made available for all individuals as needed. If Sasha is asked specific questions assessing past traumas, they will likely report childhood abuse and the more recent physical assault. Structured assessments commonly used to assess PTSD symptoms include the PTSD Checklist for DSM-5 (PCL-5),","_key":"85ece899cd910"},{"_type":"span","marks":["superscript"],"text":"11 ","_key":"9741bccf172c"},{"_type":"span","marks":[],"text":"PTSD Symptom Scale – Interview for DSM-5 (PSS-I-5),","_key":"719f8a0d30ef"},{"_type":"span","marks":["superscript"],"text":"12","_key":"a8dfabe13e7d"},{"_type":"span","marks":[],"text":" and Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).","_key":"e2d96d86b540"},{"_type":"span","marks":["superscript"],"text":"13","_key":"1fc5c376246c"},{"_type":"span","marks":[],"text":" During an initial assessment, it is vital for clinicians assessing potential traumatic experiences to gather only the information necessary to determine whether a trauma history is present and whether trauma interventions are appropriate, which does not require a full account of traumatic experiences. Requiring individuals to disclose a detailed account of their trauma history during the initial assessment poses a risk for retraumatization and may limit what the individual feels comfortable sharing. PTSD assessments only ask clients to, at most, share a brief description of the traumatic event and PTSD symptoms.","_key":"942804615eb4"}],"_type":"block","style":"normal","_key":"10d1823d4bc6"},{"children":[{"text":"Assessment is an essential component of understanding, and addressing, trauma as part of a psychosis presentation. In our clinical example, if Sasha is only assessed for psychosis and not asked questions about past traumas, they will likely receive a diagnosis of a psychotic disorder (such as ","_key":"a3c19acd92eb0","_type":"span","marks":[]},{"_type":"span","marks":["d8214a5a9350"],"text":"schizophrenia","_key":"77604a39a007"},{"marks":[],"text":") and be prescribed antipsychotic medications to reduce the occurrence of the voices and shadowy figures. Sasha may also be offered supportive psychotherapy and case management. If the clinic has trained staff, Sasha may be offered an evidence-based psychotherapeutic intervention such as cognitive behavioral therapy for psychosis (CBTp). However, the traumatic experiences would go untreated, thus limiting the potential for recovery.","_key":"3559fd194365","_type":"span"}],"_type":"block","style":"normal","_key":"a6b8aeb9f68e","markDefs":[{"href":"https://www.psychiatrictimes.com/topics/schizophrenia","_key":"d8214a5a9350","nofollow":true,"blank":true,"_type":"link"}]},{"markDefs":[],"children":[{"_type":"span","marks":["strong","em"],"text":"Clinical Pearl: ","_key":"fd9eb8545e9c0"},{"marks":[],"text":"As clients do not often report trauma experiences unless asked about them explicitly, assessment of trauma in individuals presenting with psychosis symptoms is essential. Assessing for the types of trauma experienced and PTSD symptoms, as opposed to a full account of traumatic events, is sufficient at this stage of care.","_key":"ecfb99764e01","_type":"span"}],"_type":"block","style":"normal","_key":"21cd01287ce4"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"33f834148e7a"}],"_type":"block","style":"normal","_key":"9c9613896724"},{"style":"normal","_key":"d1e421b5bec3","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Trauma-Informed Care","_key":"9765ab1dd28b0"}],"_type":"block"},{"markDefs":[],"children":[{"marks":[],"text":"SAMHSA recommends that all treatment programs take a trauma-informed approach.","_key":"b67d570f20860","_type":"span"},{"_type":"span","marks":["superscript"],"text":"1","_key":"8d86306d3ac6"},{"_type":"span","marks":[],"text":" This incorporates key principles into the organizational culture of the program. These include acknowledging the widespread impact of trauma and the path to recovery, recognizing the signs of trauma in individuals, and responding by making sure policies and practices are geared toward not retraumatizing the individual. A trauma-informed approach may or may not include trauma-specific treatments. Some fundamental principles in a trauma-informed approach are ensuring a sense of physical and psychological safety for all served; building and maintaining individuals’ trust in the program by those accessing services and their families; welcoming mutual self-help from those with lived experience of trauma and recovery from trauma; adopting a nonhierarchical, collaborative stance where the expertise of individuals accessing services is understood and respected; keeping individuals accessing services front and center, and believing in their resilience and ability to recover from trauma; and providing care that actively moves away from stereotypes and biases.","_key":"ba8723c5431d"}],"_type":"block","style":"normal","_key":"7e446c9a1681"},{"children":[{"text":"Clinical Pearl: ","_key":"22aeea7450c00","_type":"span","marks":["strong","em"]},{"text":"Programs should consider how to implement trauma-informed care and ensure staff are trained in this approach to best meet the needs of individuals accessing services.","_key":"4cb2122c8799","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"d6b894b68ec2","markDefs":[]},{"_type":"block","style":"normal","_key":"a1504d8d40cc","markDefs":[],"children":[{"text":"","_key":"6ad611286096","_type":"span","marks":[]}]},{"style":"normal","_key":"e9c37a269cc3","markDefs":[],"children":[{"marks":["strong"],"text":"Addressing Trauma","_key":"88f3e6fa02c30","_type":"span"}],"_type":"block"},{"children":[{"_type":"span","marks":[],"text":"Clinicians are often concerned about the increased sensitivity to stress in those experiencing psychosis and can be hesitant to use evidence-based treatments for PTSD.","_key":"f20c8abcc6470"},{"marks":["superscript"],"text":"14,15","_key":"d2744bce97f2","_type":"span"},{"_type":"span","marks":[],"text":" As a result, evidence-based trauma treatments are not offered routinely to individuals seeking treatment for psychosis in the United States.","_key":"3701106caee7"},{"_type":"span","marks":["superscript"],"text":"16","_key":"35b05d027c71"},{"_type":"span","marks":[],"text":" However, Grubaugh et al, in a meta-analysis of PTSD treatments for individuals diagnosed with PTSD and a “severe and persistent comorbid mental illness,” which included psychotic spectrum disorders or mood disorders, found that PTSD treatment can be used safely in this population.","_key":"1444440872d4"},{"_type":"span","marks":["superscript"],"text":"5","_key":"2fd90c84cf85"}],"_type":"block","style":"normal","_key":"bf19bb1c869d","markDefs":[]},{"style":"normal","_key":"87c3e1c1e9d9","markDefs":[],"children":[{"marks":[],"text":"In addition, a growing evidence base suggests that standard protocols for trauma treatments in psychosis are effective.","_key":"af52c57198d70","_type":"span"},{"_type":"span","marks":["superscript"],"text":"17","_key":"844c511b2b18"},{"text":" These treatment protocols include trauma-focused CBTp,","_key":"b806af46327e","_type":"span","marks":[]},{"text":"18","_key":"961c7f1dc092","_type":"span","marks":["superscript"]},{"_key":"761eaf8e1bed","_type":"span","marks":[],"text":" prolonged exposure,"},{"text":"19","_key":"533e62e1f515","_type":"span","marks":["superscript"]},{"_type":"span","marks":[],"text":" and eye movement desensitization reprocessing.","_key":"bd1e88d694b7"},{"marks":["superscript"],"text":"20","_key":"a40fb0106e08","_type":"span"},{"_type":"span","marks":[],"text":" However, adapting these protocols may be necessary to ensure the needs of an individual experiencing psychosis symptoms are thoroughly addressed; for example, ensuring the individual has sufficient coping skills in place to tolerate the trauma intervention while not prolonging access to exposure-based therapies (“as much as needed, but as little as necessary”) and supporting the individual around psychosis symptoms if these are intrusive and may impact the trauma treatment. Developing an initial formulation to understand the trauma timeline, subsequent symptoms (both trauma and psychosis focused), and impact of these on core beliefs will aid the clinician in determining where to focus psychosocial interventions.","_key":"b559930bfda4"}],"_type":"block"},{"style":"normal","_key":"3d54d81ab544","markDefs":[],"children":[{"text":"Clinical Pearl:","_key":"b5b3e14824a50","_type":"span","marks":["strong","em"]},{"_type":"span","marks":[],"text":" Treatment options and pacing are guided by the immediate needs of the individual and should support the reduction of distress and movement toward meaningful goals.","_key":"09df86fc96fc"}],"_type":"block"},{"style":"normal","_key":"c6ba35812f68","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"ceadb6aed9cd"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Concluding Thoughts","_key":"6c96206f90d20"}],"_type":"block","style":"normal","_key":"04c89206a160"},{"children":[{"_type":"span","marks":[],"text":"Traumatic life events are common among individuals who experience psychosis. Often, when an individual presents with psychosis, past traumas are not assessed. This could be due to the individual’s hesitancy to talk about these events or the clinician’s fear that asking about trauma will exacerbate symptoms. We now know that trauma-informed care leads to better outcomes. This systemwide approach begins with creating safe spaces for individuals to speak about past experiences in a way that is not retraumatizing and incorporates the impact of these experiences into a formulation that guides treatment. Evidence-based trauma interventions have been shown to be effective in addressing trauma in individuals experiencing psychosis and should be made routinely available. Further research on effective trauma intervention adaptations for individuals with psychosis would be meaningful. We encourage all clinicians who support individuals experiencing psychosis to provide trauma- informed care across treatment settings.","_key":"a5ecb30f9ece0"}],"_type":"block","style":"normal","_key":"54ee64fccb50","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"2f2dc6a7b49d"}],"_type":"block","style":"normal","_key":"5e4006ea3d7d"},{"_type":"block","style":"normal","_key":"6d6dd3a97886","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Dr Chari","_key":"58e1667f91790"},{"_type":"span","marks":[],"text":" ","_key":"5cf65405f242"},{"_type":"span","marks":["em"],"text":"is the assistant psychosocial director and didactic lead of the INSPIRE Clinic and a clinical associate professor in the Department of Psychiatry and Behavioral Sciences at Stanford University School of Medicine in California. ","_key":"e866b43f1ed2"},{"_type":"span","marks":["strong"],"text":"Dr Lee","_key":"ccb4f0afd429"},{"_type":"span","marks":[],"text":" ","_key":"2f0e11fb3a7f"},{"_type":"span","marks":["em"],"text":"is a clinical assistant professor and a California-licensed clinical psychologist in the Department of Psychiatry and Behavioral Sciences at Stanford University School of Medicine.","_key":"7b4d350db1c9"},{"text":" ","_key":"354ee8181f6a","_type":"span","marks":["em","strong"]},{"_type":"span","marks":["strong"],"text":"Dr Olson","_key":"00a55572510f"},{"_type":"span","marks":["em"],"text":" is a clinical associate professor and licensed psychologist in the INSPIRE Clinic and dialectical behavior therapy program at Stanford University.","_key":"064317cd6de7"},{"text":" ","_key":"e5ddf42511aa","_type":"span","marks":[]},{"marks":["strong"],"text":"Dr Hardy","_key":"361261b71957","_type":"span"},{"text":" is the codirector of the INSPIRE Clinic, the co–section chief of INSPIRE Section, and a clinical professor in the Department of Psychiatry and Behavioral Sciences at Stanford University School of Medicine.","_key":"2ae2be231aa1","_type":"span","marks":["em"]}]},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"","_key":"571f1168fb33"}],"_type":"block","style":"normal","_key":"005a3e2c28bd"},{"children":[{"_type":"span","marks":["strong"],"text":"References","_key":"78ff24c7b93a0"}],"_type":"block","style":"normal","_key":"8d33c20439ca","markDefs":[]},{"_type":"block","style":"normal","_key":"65064370f438","markDefs":[{"href":"https://ncsacw.acf.hhs.gov/userfiles/files/SAMHSA_Trauma.pdf","_key":"0ce96c8b2d16","blank":true,"_type":"link"}],"children":[{"marks":[],"text":"1. Substance Abuse and Mental Health Services Administration. ","_key":"4cd7d88fbc060","_type":"span"},{"_type":"span","marks":["em"],"text":"SAMHSA’s Concept of Trauma and Guidance for a Trauma-Informed Approach","_key":"4cd7d88fbc061"},{"_type":"span","marks":[],"text":". Substance Abuse and Mental Health Services Administration; 2014. HHS Publication No. (SMA) 14-4884. Accessed September 25, 2024. ","_key":"4cd7d88fbc062"},{"_type":"span","marks":["0ce96c8b2d16"],"text":"https://ncsacw.acf.hhs.gov/userfiles/files/SAMHSA_Trauma.pdf","_key":"4cd7d88fbc063"}]},{"_type":"block","style":"normal","_key":"fd9a524350bb","markDefs":[{"blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/16023620/","_key":"1fe6fbca1660"}],"children":[{"_type":"span","marks":[],"text":"2. Kessler RC, Birnbaum H, Demler O, et al. ","_key":"024ba5700fc90"},{"_type":"span","marks":["1fe6fbca1660"],"text":"The prevalence and correlates of nonaffective psychosis in the National Comorbidity Survey Replication (NCS-R).","_key":"024ba5700fc91"},{"_type":"span","marks":[],"text":" ","_key":"7c5b46a5e614"},{"_key":"024ba5700fc92","_type":"span","marks":["em"],"text":"Biol Psychiatry"},{"_type":"span","marks":[],"text":". 2005;58(8)668-676.","_key":"024ba5700fc93"}]},{"style":"normal","_key":"a7cdf1dd1c8d","markDefs":[{"blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/19959704/","_key":"2f4dd8eb6b96"}],"children":[{"_type":"span","marks":[],"text":"3. Achim AM, Maziade M, Raymond E, et al. ","_key":"7d61c21346920"},{"text":"How prevalent are anxiety disorders in schizophrenia? 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Psychosis","url":{"current":"opening-pandoras-box-the-importance-of-assessing-and-treating-trauma-in-individuals-experiencing-psychosis","_type":"slug"},"thumbnail":{"_type":"mainImage","alt":"trauma","caption":"necropos12/AdobeStock","asset":{"_ref":"image-3baa097f1742d64c9afda10b2c6f7deda469f1dc-7280x4080-jpg","_type":"reference"}},"published":"2024-11-12T16:00:00.000Z"}]},{"authors":[{"displayName":"Vania Modesto-Lowe, MD, MPH","url":"vania-modesto-lowe-md-mph"},{"displayName":"Roberto León-Barriera, MD","url":"roberto-leon-barriera-md"},{"displayName":"Jasleen Kaur, MD","url":"jasleen-kaur-md"}],"taxonomyMapping":[{"identifier":"topics/drug-watch","_rev":"iT1zwftgutzeOHGWL8VPIf","usedForRecommendations":false,"parent":{"isMainTopic":true,"_createdAt":"2020-03-26T06:11:21Z","_rev":"uvXJooXtzvjNOyx50HTt8m","identifier":"topics","_type":"taxonomy","name":"Topics","_id":"pst_taxonomy_53202_clinical","_updatedAt":"2023-03-31T19:15:59Z","parent":null},"name":"Drug Watch","_id":"01583c5c-f3f9-433a-a948-ce2d3bbdc164","video":{"isTaxVideo":false},"pixelTrackingCode":null,"_createdAt":"2024-04-24T15:53:24Z","_type":"taxonomy","_updatedAt":"2024-04-24T15:53:24Z"},{"_createdAt":"2020-03-26T06:11:21Z","name":"Psychopharmacology","parent":{"_createdAt":"2020-03-26T06:11:21Z","identifier":"topics","isMainTopic":true,"_id":"pst_taxonomy_53202_clinical","_updatedAt":"2023-03-31T19:15:59Z","parent":null,"_rev":"uvXJooXtzvjNOyx50HTt8m","_type":"taxonomy","name":"Topics"},"_type":"taxonomy","pixelTrackingCode":null,"cmeType":"per","perKeywordMapping":["Psychiatry","Neurology","New Drugs"],"_rev":"4roekEga8ZReQAdH6zkAp9","_id":"pst_taxonomy_336_psychopharmacology","_updatedAt":"2023-03-31T19:23:25Z","identifier":"topics/psychopharmacology"}],"gptTakeaways":"• Metformin is being investigated for anti-aging benefits, potentially reducing age-related diseases by influencing cellular mechanisms like inflammation and oxidative stress.\n\n• It may improve gut microbiota composition, enhancing glucose homeostasis and reducing inflammation, contributing to its potential geroprotective effects.\n\n• Despite promising preclinical and observational data, metformin's anti-aging effects remain investigational, with ongoing studies like the TAME trial seeking to clarify its impact.","url":"happy-accidents-repurposing-metformin","authorMapping":[{"_type":"author","_id":"836eee56-9777-417a-b38b-223bffc82e71","biography":[{"_key":"58ceba28b0d9","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Dr Modesto-Lowe ","_key":"fcf5f5d48c510"},{"_type":"span","marks":["em"],"text":"is medical director at Hartford Behavioral Health and community faculty at the University of Connecticut.","_key":"fcf5f5d48c511"}],"_type":"block","style":"normal"}],"_updatedAt":"2024-06-17T16:34:51Z","url":{"current":"vania-modesto-lowe-md-mph","_type":"slug"},"displayName":"Vania Modesto-Lowe, MD, MPH","_createdAt":"2024-06-17T16:34:51Z","_rev":"w3c4fqW02PkQg1BodJs8ZI"},{"_rev":"d1TxKWMXiaV9tOPzmABqL2","_type":"author","_id":"c63b1f36-b3ee-4097-9a81-244f18b40ffc","biography":[{"markDefs":[],"children":[{"marks":["strong"],"text":"Dr León-Barriera ","_key":"668182e5b5dd0","_type":"span"},{"_type":"span","marks":["em"],"text":"is an assistant professor of psychiatry at the University of Pittsburgh School of Medicine.","_key":"668182e5b5dd1"}],"_type":"block","style":"normal","_key":"dfdc70654ec3"}],"_updatedAt":"2024-06-17T16:35:25Z","url":{"current":"roberto-leon-barriera-md","_type":"slug"},"displayName":"Roberto León-Barriera, MD","_createdAt":"2024-06-17T16:35:25Z"},{"_id":"d5a4178c-8918-4266-b725-a3a62c688498","biography":[{"style":"normal","_key":"cf15a37b3746","markDefs":[],"children":[{"marks":["strong"],"text":"Dr Kaur ","_key":"c98f5ed7c8010","_type":"span"},{"_type":"span","marks":["em"],"text":"is a principal psychiatrist at the Connecticut Valley Hospital.","_key":"c98f5ed7c8011"}],"_type":"block"}],"_updatedAt":"2024-06-17T16:35:51Z","url":{"current":"jasleen-kaur-md","_type":"slug"},"displayName":"Jasleen Kaur, MD","_createdAt":"2024-06-17T16:35:51Z","_rev":"d1TxKWMXiaV9tOPzmABqXP","_type":"author"}],"issueGroup":{"_ref":"7d283d85-869a-4578-b7e0-00266f149eb6","_type":"reference"},"_updatedAt":"2024-11-11T17:55:35Z","gptSummary":"Metformin, a widely prescribed antidiabetic medication, is being explored for its potential anti-aging benefits. Evidence suggests metformin may reduce age-related diseases, such as cancer and cardiovascular conditions, by influencing cellular mechanisms like inflammation and oxidative stress. It may also improve gut microbiota composition, enhancing glucose homeostasis and reducing inflammation. Despite promising preclinical and observational data, metformin's anti-aging effects remain investigational. Ongoing studies, including the TAME trial, aim to clarify its potential geroprotective properties and impact on health span and life span.","factCheckAuthors":null,"documentGroupMapping":null,"_type":"article","ExcludeFromPubMedXML":false,"drugMentions":"{\"drug_mentions\": [\"metformin\", \"chlorpromazine\", \"glucagon-like peptide-1\"]}","_rev":"bcxmLYb4HqB4YfW9fqUjI6","title":"“Happy Accidents”: Repurposing Metformin","articleType":"Publication","documentGroup":null,"thumbnail":{"_type":"mainImage","alt":"metformin","asset":{"_ref":"image-e043699441b7cb5a79c8ffaaeb75a30836c12c9d-2048x2048-jpg","_type":"reference"}},"is_visible":true,"audioUrl":"https://s3.us-east-1.amazonaws.com/ai-generated-audios/www.psychiatrictimes.com/c3ee4298-c307-4ce7-a06a-cb1e13e08012_1731347734929.f7863427-e004-46a3-9ff8-53cf30f2817f.mp3","factCheckAuthorMapping":null,"_id":"c3ee4298-c307-4ce7-a06a-cb1e13e08012","published":"2024-11-11T18:00:18.436Z","summary":"There is an accumulating body of evidence that metformin may have benefits in aging beyond its effect on glycemic control.","body":[{"asset":{"_ref":"image-e043699441b7cb5a79c8ffaaeb75a30836c12c9d-2048x2048-jpg","_type":"reference"},"widthP":50,"disableTextWrap":false,"disableLightBox":true,"_type":"figure","alt":"metformin","_key":"8ebcfb14ed94","alignment":"left"},{"_key":"84c0e2ff246f","markDefs":[],"children":[{"_type":"span","marks":[],"text":"A recent article on the multiple uses of metformin brings up the important topic of repurposing medications.","_key":"bdf42da2b97f0"},{"marks":["superscript"],"text":"1","_key":"5491a79ae1b3","_type":"span"},{"_type":"span","marks":[],"text":" Repurposing has been around since the advent of modern medicine. One prominent example is the use of chlorpromazine (CPZ) as an antipsychotic.","_key":"57788e4101da"},{"_type":"span","marks":["superscript"],"text":"2","_key":"63808ee8df77"},{"_type":"span","marks":[],"text":" Chlorpromazine was first synthesized in 1951 as a potentiator of general anesthesia.","_key":"6d01330aaf36"},{"_type":"span","marks":["superscript"],"text":"2","_key":"4e630420cd93"},{"text":" The psychiatric benefits were found later by Henri Laborit, a surgeon in the French army, who was doing research with artificial hibernation in the prevention of surgical shock. Laborit employed CPZ as an adjunct to anesthetics. He observed that CPZ at doses of 50 mg to 100 mg produced a lowering of body temperature, sedation, and disinterest without loss of consciousness. He was able to persuade his colleagues in the military hospital in Paris, France, to try CPZ in the treatment of a patient who was experiencing psychotic agitation. The mechanism of action was not fully known, and it was thought that it worked in controlling agitation because of its cooling effect and induction of artificial hibernation in patients.","_key":"0248a8cec900","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"2","_key":"bf265fface94"},{"_key":"fddf3b368355","_type":"span","marks":[],"text":" The pharmacological mechanism was not fully understood until many years later, and the way it has impacted the practice of psychiatry needs no introduction."}],"_type":"block","style":"normal"},{"children":[{"marks":[],"text":"These happy accidents in medicine have played a vital role in getting where we are right now in patient care compared with just 50 years ago. This begs the question, are we onto another happy accident with metformin? There is an accumulating body of evidence that metformin may have benefits in aging beyond its effect on glycemic control.","_key":"b0c3fe283bd90","_type":"span"},{"_type":"span","marks":["superscript"],"text":"3","_key":"30ea0ef1ce7f"}],"_type":"block","style":"normal","_key":"7fac76e86563","markDefs":[]},{"_key":"14e6ebfe8a30","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Repurposing Metformin","_key":"aa9a379177900"}],"_type":"block","style":"normal"},{"children":[{"_type":"span","marks":[],"text":"Metformin is endorsed by the American Diabetes Association and the European Association for the Study of Diabetes as initial therapy for patients with type 2 diabetes (T2D), and it is one of the most prescribed antidiabetic medications worldwide.","_key":"06d6fee7cace0"},{"_type":"span","marks":["superscript"],"text":"4","_key":"f1cb215206b1"},{"_type":"span","marks":[],"text":" It is widely recognized that metformin improves hyperglycemia and insulin sensitivity.","_key":"f1e0932e8960"},{"text":"4","_key":"975b9db5a95e","_type":"span","marks":["superscript"]},{"_type":"span","marks":[],"text":" Recently, the observation that metformin decreased the development of certain age-associated pathology in individuals with and without diabetes has garnered attention.","_key":"709fcd30bf33"},{"_type":"span","marks":["superscript"],"text":"3","_key":"033e25ef7b30"},{"_type":"span","marks":[],"text":" Aging refers to the time-dependent physiological loss of cellular integrity","_key":"0742cbf9a273"},{"_type":"span","marks":["superscript"],"text":"5","_key":"4e32b9347666"},{"_type":"span","marks":[],"text":" and is associated with T2D, dementia, cancer, and cardiovascular disease.","_key":"3737df516fee"},{"_type":"span","marks":["superscript"],"text":"6","_key":"7b5b5e24bc18"},{"_type":"span","marks":[],"text":" The United Kingdom Prospective Diabetes Study has shown that metformin is associated with a lower all-cause mortality rate in patients with diabetes.","_key":"c6aecba4cff4"},{"marks":["superscript"],"text":"7","_key":"ed81224bc2e0","_type":"span"},{"_type":"span","marks":[],"text":" This study was a 20-year randomized multicenter longitudinal study, and researchers found cardiovascular benefits of metformin in patients with diabetes.","_key":"ce30c364f03e"},{"_type":"span","marks":["superscript"],"text":"7","_key":"f1ddc8dd0418"},{"_type":"span","marks":[],"text":" Similarly, a systematic review of 53 studies showed that metformin use resulted in a decrease in all-cause mortality linked with aging-related diseases such as cancer and cardiovascular disease.","_key":"96a5bcd7b950"},{"_key":"f1173eed37a8","_type":"span","marks":["superscript"],"text":"8"},{"_type":"span","marks":[],"text":" As the aging population grows and life expectancy increases, we are searching for ways to maintain quality of life for as long as possible.","_key":"851909c44ac8"}],"_type":"block","style":"normal","_key":"dda1f07781a7","markDefs":[]},{"children":[{"_type":"span","marks":[],"text":"In the US, advances in health care and public health have afforded increases in life expectancy.","_key":"b21e3742dcb40"},{"text":"5","_key":"0f9339c87b3d","_type":"span","marks":["superscript"]},{"_type":"span","marks":[],"text":" Unfortunately, this longevity has been accompanied by an increase in the incidence of age-related diseases, which leads to a decreased quality of life.","_key":"c56da861efe7"},{"_key":"eac32f92cac5","_type":"span","marks":["superscript"],"text":"5"},{"_type":"span","marks":[],"text":" Health span refers to the life period in which one is healthy and free from chronic illness and aging-related dysfunction; it serves as a proxy for quality of life during the older years.","_key":"1c980fc82b14"},{"_type":"span","marks":["superscript"],"text":"6","_key":"d7266bcbe7d9"},{"_type":"span","marks":[],"text":" There is a pressing need for interventions that can delay age-associated diseases and improve health span. Preclinical data indicate that metformin may influence cellular mechanisms associated with aging, including inflammation, oxidative stress, cell senescence, and autophagy.","_key":"0e666333917a"},{"marks":["superscript"],"text":"3,5","_key":"536d6ccc4c78","_type":"span"},{"_type":"span","marks":[],"text":" Of note, metformin mimics the metabolic actions of caloric restriction, which is a recognized strategy to prolong health and life span in mammals.","_key":"d6745c91351a"},{"_type":"span","marks":["superscript"],"text":"9","_key":"05f3f1c21f0d"},{"text":" Metformin may also mimic the geroprotective effects of exercise.","_key":"acda869d7c33","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"5","_key":"75b714e72f29"},{"_type":"span","marks":[],"text":" Since metformin is inexpensive and offers a good tolerability and safety profile, it is attractive as a focus of antiaging research.","_key":"9c3ef26dd42f"},{"_type":"span","marks":["superscript"],"text":"3","_key":"0c81f29f4808"}],"_type":"block","style":"normal","_key":"898f9e41d9ea","markDefs":[]},{"_key":"6f4731648f18","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Reducing Inflammation","_key":"ba9f35da59e00"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"f55f70c04179","markDefs":[],"children":[{"_type":"span","marks":[],"text":"As early as 1907, Élie Metchnikoff theorized that cell senescence resulted from chronic systemic inflammation due to increased permeability in the colon, and the escape of bacteria and their toxic metabolites into the systemic circulation.10 Accordingly, these toxic bacterial products activated phagocytes and an inflammatory response that led to death of adjacent tissues.","_key":"67ffac31606c0"},{"text":"11","_key":"9a83f83e277c","_type":"span","marks":["superscript"]},{"_type":"span","marks":[],"text":" Interestingly, more than a century later, aging is thought to be associated with a persistent low-grade inflammation, referred to as ","_key":"4eda992e53e0"},{"text":"inflammaging","_key":"a4950ba0a33f","_type":"span","marks":["em"]},{"_type":"span","marks":[],"text":", that originates in the gut.","_key":"adcc3daab207"},{"_type":"span","marks":["superscript"],"text":"11","_key":"a4b5af286d03"},{"_type":"span","marks":[],"text":" We now know that the intestinal mucosal layer is a key modulator of inflammatory responses, protecting against invasion of dietary and microbial antigens and lumen contents. With aging there is a reduction in thickness of this mucus layer, resulting in weakened intestinal barrier function. The term ","_key":"ce8227013417"},{"text":"leaky gut","_key":"971f33dbd4a2","_type":"span","marks":["em"]},{"_type":"span","marks":[],"text":" refers to excessive bacterial translocation from the intestinal lumen into the systemic circulation, which triggers inflammatory cascades and low-grade chronic inflammation. Results of recent research in mice lend support to the hypothesis that metformin may decrease inflammation by maintaining the integrity of the intestinal barrier.","_key":"ed74a6dadd30"},{"marks":["superscript"],"text":"12","_key":"a3a5b907b15c","_type":"span"}]},{"_type":"block","style":"normal","_key":"295d9b8efc6a","markDefs":[],"children":[{"_key":"800a366150060","_type":"span","marks":[],"text":"In one study, metformin significantly decreased bacterial translocation in older mice and the expression of inflammatory markers such as interleukins (ILs) and tumor necrosis factor α."},{"marks":["superscript"],"text":"12","_key":"0cfb1a6c1850","_type":"span"},{"_type":"span","marks":[],"text":" In addition to low-grade inflammation, contemporary views of aging suggest a decline in several mediators of cell maintenance.","_key":"5d9ed0e1bf39"},{"_key":"67df2baf9e08","_type":"span","marks":["superscript"],"text":"5"},{"_type":"span","marks":[],"text":" For example, autophagy (a cellular recycling program that removes dysfunctional organelles from the cytoplasm) deteriorates with aging.","_key":"848a603bb9aa"},{"_type":"span","marks":["superscript"],"text":"5","_key":"707bd5e0da72"},{"_type":"span","marks":[],"text":" Of interest, metformin has been implicated in improving autophagy and slowing several cellular mechanisms of aging.","_key":"258d1f409e75"},{"_key":"4c3a8e06e572","_type":"span","marks":["superscript"],"text":"5"},{"_key":"87babbf490d0","_type":"span","marks":[],"text":" It has been posited that metformin’s anti-inflammatory effects modulate cellular integrity by maintenance of cell-to-cell communication, leading to a reduction in proinflammatory cytokines."},{"text":"3","_key":"13fcb52d2b7a","_type":"span","marks":["superscript"]}]},{"style":"normal","_key":"4cf19120eca8","markDefs":[],"children":[{"_type":"span","marks":[],"text":"In addition to chronic inflammation and dysregulation of cell-cell connectivity, other hallmarks of aging include mitochondrial dysfunction, genomic instability, and oxidative stress.","_key":"607b146a243e0"},{"_type":"span","marks":["superscript"],"text":"3","_key":"f54b4bf052cb"},{"text":" Although knowledge of metformin’s effects on these aging processes remains elusive, there is increasing interest in this field. One example is the Metformin in Longevity Study (MILES; NCT02432287), a double-blind, placebo-controlled clinical study that included 14 patients. Researchers sought to establish associations between 6-week metformin intake and youthful gene expression in older persons with impaired glucose tolerance.","_key":"e3a2759a9a60","_type":"span","marks":[]},{"_key":"b0f481c886b3","_type":"span","marks":["superscript"],"text":"13"},{"marks":[],"text":" Preliminary results indicate that in older individuals, metformin is implicated in metabolic changes, including DNA repair in the muscle tissue and mitochondrial fatty acid oxidation in the adipose tissue.","_key":"913aa07e6624","_type":"span"},{"marks":["superscript"],"text":"6,13","_key":"cd57411e06fd","_type":"span"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Early on, the antidiabetic benefits of metformin were deemed to occur via decreased lipogenesis and gluconeogenesis in the liver because of its impact on molecular signaling and mitochondrial function.","_key":"92696997ef930"},{"_type":"span","marks":["superscript"],"text":"3","_key":"46ca5b922f64"},{"_type":"span","marks":[],"text":" The end result was a decrease in plasma glucose and decreased insulin resistance.","_key":"62ede7391789"},{"_key":"1cf738f968c6","_type":"span","marks":["superscript"],"text":"3"},{"text":" Metformin also exerts action in extrahepatic sites such as the gut. After oral administration, metformin concentrations in the intestinal lumen are significantly higher than in the systemic circulation.","_key":"183201f2ed1c","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"14","_key":"eab906a2b0f1"},{"text":" Metformin exerts many actions within the gut, such as an increase in lactate production and intestinal glucose uptake, an increase in glucagon-like peptide-1 (GLP-1), and advantageous changes in the gut microbiota.","_key":"7fc4591f9d96","_type":"span","marks":[]},{"_key":"7197224f33b9","_type":"span","marks":["superscript"],"text":"14"},{"_type":"span","marks":[],"text":" The gut microbiota is an ecosystem that interacts in a symbiotic fashion with the host to promote health.","_key":"f761270411f9"},{"_key":"a98ecdd92b2a","_type":"span","marks":["superscript"],"text":"15"},{"_type":"span","marks":[],"text":" The microbiota impacts vitamin and short-chain fatty acid production, digestion, immunity, and the permeability of the intestinal barrier.","_key":"ea580290ac99"},{"_type":"span","marks":["superscript"],"text":"15","_key":"6d1fcfac8007"},{"text":" With aging, there are changes in the gut microbiome leading to increased inflammation, gut permeability, and release of proinflammatory cytokines.","_key":"318f63ce3ab3","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"11","_key":"3079a4a577f2"},{"_key":"23e7c8cef248","_type":"span","marks":[],"text":" Metformin may improve the gut microbe composition by increasing the ratio of bacteria that produce anti-inflammatory short chain fatty acids (SFCAs)."},{"text":"16","_key":"35627fe68f52","_type":"span","marks":["superscript"]},{"_type":"span","marks":[],"text":" These bacteria ferment dietary carbohydrates that humans cannot digest.","_key":"057002cfde4b"},{"_type":"span","marks":["superscript"],"text":"16","_key":"14fc4a784ada"},{"_type":"span","marks":[],"text":" SCFAs are widely known for enhancing glucose homeostasis in adipose tissue, liver, and muscles.","_key":"f988f93121f3"},{"_type":"span","marks":["superscript"],"text":"16","_key":"8fb2600e6096"},{"_type":"span","marks":[],"text":" Metformin also reduces the abundance of proinflammatory bacterial species supporting the integrity of the intestinal barrier.","_key":"81a0e45c8014"},{"marks":["superscript"],"text":"12","_key":"eb4abd61b50c","_type":"span"},{"text":" In animal studies, metformin expanded the gut population of ","_key":"cc75fa8c9558","_type":"span","marks":[]},{"_type":"span","marks":["em"],"text":"Akkermansia","_key":"a6167e8d3934"},{"_type":"span","marks":[],"text":" spp, a producer of short-chain fatty acids that is correlated with a decrease in adipose tissue inflammation.16 Although human studies are yet to uncover a metformin signature on the gut microbiome, this is an area that merits further examination.","_key":"d3e58e05610c"},{"_type":"span","marks":["superscript"],"text":"16","_key":"63840f62a8d4"}],"_type":"block","style":"normal","_key":"73a7f73e6d72"},{"children":[{"_type":"span","marks":["strong"],"text":"Anticancer Effects","_key":"5f2cc84aaeb60"}],"_type":"block","style":"normal","_key":"4fb1300d4915","markDefs":[]},{"children":[{"_type":"span","marks":[],"text":"In terms of aging-related diseases, there has been interest in exploring the putative anticancer actions of metformin. Preclinical evidence has shown that metformin inhibits tumor growth and metastasis in mouse models for head and neck squamous cell carcinoma, hepatocellular carcinoma, and breast cancer.","_key":"879cfb84df880"},{"_type":"span","marks":["superscript"],"text":"9","_key":"e04a5705068e"},{"_type":"span","marks":[],"text":" Observational studies have also revealed that metformin exerts beneficial effects on individuals with diabetes who also have comorbid cancer.","_key":"752241ccbd85"},{"_type":"span","marks":["superscript"],"text":"9","_key":"65488d3d600d"},{"_type":"span","marks":[],"text":" Recent attempts to explore whether metformin decreases the incidence of age-related disease in humans have yielded variable results. Notably, the largest randomized trial of metformin as adjuvant treatment for breast cancer (N = 3649 women, 5-year follow-up) found no advantage of metformin in measures of disease-free survival or overall survival.","_key":"6207d380f7fc"},{"_type":"span","marks":["superscript"],"text":"9","_key":"c20ba9c15a85"},{"text":" Whether metformin can delay the onset of other age-associated cancer and pathology remains unclear.","_key":"a0bf1b68d57b","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"fa3b304ce712","markDefs":[]},{"children":[{"_key":"f20573a7f2b40","_type":"span","marks":["strong"],"text":"Neuroprotective Effects"}],"_type":"block","style":"normal","_key":"6b26c11ddbc0","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Finally, a neuroprotective effect of metformin has also been proposed. Aging and neurodegenerative disease share similar cellular dysfunction patterns, including inflammation, oxidative stress, and mitochondrial dysfunction. It is possible that regulation of glucose metabolism and insulin sensitivity may counter some of these cellular processes. In 5528 patients with diabetes with a median follow-up of 5.2 years, prolonged metformin use (\u003e 2 years) significantly decreased the risk of developing neurodegenerative disorders.","_key":"05ae61429d830"},{"text":"17","_key":"7af7604a4b66","_type":"span","marks":["superscript"]},{"_key":"f6141d94acda","_type":"span","marks":[],"text":" However, in a subsequent meta-analysis, metformin did not decrease the risk of developing Alzheimer disease.17 Doubts about the neurocognitive effects of metformin persist. Does long-term metformin treatment alter the risk of cognitive decline?"}],"_type":"block","style":"normal","_key":"dedc390636a7"},{"_key":"0a36ebb4e75f","markDefs":[],"children":[{"marks":[],"text":"Major efforts to clarify these putative effects include the Targeting Aging With Metformin (TAME) trial, which is a large double-blind, placebo-controlled study that seeks to establish antiaging properties of metformin.","_key":"e55ef0fa77640","_type":"span"},{"_type":"span","marks":["superscript"],"text":"18","_key":"18c23f4046a3"},{"_type":"span","marks":[],"text":" Specifically, the TAME trial aims to examine whether giving metformin to healthy individuals delays the onset of aging-associated diseases.18 It will include 3000 participants aged 65 to 79 years, and it is the first large trial for geroprotective medications.","_key":"63279bb71faf"},{"text":"18","_key":"b13dfd23b892","_type":"span","marks":["superscript"]}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"e7a3e448ff05","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Concluding Thoughts","_key":"cbfdef33f8d50"}]},{"_type":"block","style":"normal","_key":"652263f9a7cc","markDefs":[],"children":[{"_type":"span","marks":[],"text":"In sum, the repurposing of metformin has been of research and clinical interest worldwide. 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