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1.1.9 2 2 2h16c1.1 0 2-.9 2-2V6zm-2 0l-8 4.99L4 6h16zm0 12H4V8l8 5 8-5v10z"></path></svg></button></button><button class="group mb-4 "><a class="cursor-pointer flex justify-center"><svg stroke="currentColor" fill="none" stroke-width="2" viewBox="0 0 24 24" stroke-linecap="round" stroke-linejoin="round" style="color:#818285;margin-bottom:6px;background:white;cursor:pointer" height="1.25rem" width="1.25rem" xmlns="http://www.w3.org/2000/svg"><polyline points="6 9 6 2 18 2 18 9"></polyline><path d="M6 18H4a2 2 0 0 1-2-2v-5a2 2 0 0 1 2-2h16a2 2 0 0 1 2 2v5a2 2 0 0 1-2 2h-2"></path><rect x="6" y="14" width="12" height="8"></rect></svg></a></button></div></div><div><div class="flex flex-wrap"><p class=" text-primary font-semibold">Podcast</p><div class="h-[16px] border-l-2 border-gray-400 mt-1 mx-1 "></div><time class="text-gray-500 " dateTime="2016-08-15T20:13:35.000">August 15, 2016</time></div><h1 class="text-[26px] font-medium leading-8">ADHD in Older Adults</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/david-w-goodman-md">David W. Goodman, MD</a></span></div></div></div><div class="max-w-full"><div class="flex flex-wrap sm:flex-nowrap items-center w-fit my-2"></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="ADHD in Older Adults" 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="ADHD in Older Adults" 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></div></div></div><div class=" lg:w-full flex flex-col lg:flex-row lg:items-center lg:justify-end"></div><p class="py-2 mb-2 text-sm italic text-gray-600">An expert discusses ADHD in patients over 50.</p><div class="py-2"><div class="blockText_blockContent__TbCXh"><div class=""><div style="width:auto%;float:right;max-width:525px;margin:0 0 1.5rem 1.5rem;clear:both;cursor:pointer" 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=%271000%27%20height=%27604%27/%3e"/></span><img alt="" title="" 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="" title="" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2F0566cbf15de9d5cd6f9e2ddb91aa6037d0b1d35c-1000x604.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1080&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2F0566cbf15de9d5cd6f9e2ddb91aa6037d0b1d35c-1000x604.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=2048&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2F0566cbf15de9d5cd6f9e2ddb91aa6037d0b1d35c-1000x604.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=2048&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><p class="text-gray-500 italic text-sm">©ValeriPotapova/ Shutterstock</p><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/0566cbf15de9d5cd6f9e2ddb91aa6037d0b1d35c-1000x604.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><div class="audio d-block text-center mb-3"><audio controls="" controlsList="nodownload" class="audio w-full"><source src="https://cdn.sanity.io/files/0vv8moc6/psychtimes/977652c31dc94707cc6b8a7df14212e7ac8bda23.mp3" type="audio/ogg"/><source src="https://cdn.sanity.io/files/0vv8moc6/psychtimes/977652c31dc94707cc6b8a7df14212e7ac8bda23.mp3" type="audio/mpeg"/>Your browser does not support the audio element.</audio></div><p class="pb-2"> </p><p class="pb-2">For which patients over 50 who complain of cognitive difficulty should ADHD be considered in the differential? What are the treatment options for older adults with this diagnosis? David Goodman, MD, FAPA addresses both questions in this brief podcast.</p><p class="pb-2">Dr Goodman is Assistant Professor of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine. He is also Director of the Adult Attention Deficit Disorder Center of Maryland in Lutherville, and Director of Suburban Psychiatric Associates, LLC.</p><p class="pb-2">A principal investigator for multi-site Phase II and III drug trials for the treatment of adult ADHD and major depression, Dr Goodman is the lead author on the largest published adult ADHD trial. He is also lead author on the <a rel="nofollow noreferrer noopener" target="_blank" href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3505127/">largest survey assessment</a> of physician clinical practice for adults with ADHD.</p><p class="pb-2"><strong>Discussed in this podcast:</strong></p><p class="pb-2"><a rel="nofollow noreferrer noopener" target="_blank" href="http://link.springer.com/article/10.1007%2Fs40266-015-0327-0">Clinical Presentation, Diagnosis and Treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in Older Adults: A Review of the Evidence and its Implications for Clinical Care.</a></p><p class="pb-2"><a rel="nofollow noreferrer noopener" target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed/23514676">Quality of Life in Adults Aged 50+ With ADHD</a></p><p class="pb-2"><a rel="nofollow noreferrer noopener" target="_blank" href="http://jad.sagepub.com/content/19/5/380">Psychopharmacological Treatment of ADHD in Adults Aged 50+: An Empirical Study</a></p><p class="pb-2"><a rel="nofollow noreferrer noopener" target="_blank" href="http://bjp.rcpsych.org/content/201/4/298.long">Prevalence of Attention-Deficit Hyperactivity Disorder in Older Adults in The Netherlands</a></p><p class="pb-2"><a rel="nofollow noreferrer noopener" target="_blank" href="http://jad.sagepub.com/content/16/4/333">The Identification and Assessment of Late-Life ADHD in Memory Clinics</a></p></div></div><div class="flex items-center lg:w-3/4 mb-4 pb-12"></div><div class="jsx-19ede9f0a5a45918 py-4 relative bg-primary md:px-8 -ml-6 xs:ml-0 w-screen xs:w-auto"><div class="jsx-19ede9f0a5a45918 px-4 sm:px-0"><div class="flex justify-between items-center py-1 space-x-4 border-0 select-none sm:border-b border-secondary"><div class="text-3xl text-white text-lg sm:text-3xl">Related Videos</div></div></div><div style="scroll-snap-type:none" class="jsx-19ede9f0a5a45918 flex items-start overflow-x-auto space-x-4 py-4 relative mx-auto w-full pl-4"><a id="" class="w-[200px] h-fit 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El-Mallakh, MD</a><span class="jsx-ad50481d5ee26850 mr-1 ml-[1px]"> </span><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/irem-hacisalihoglu-aydin-md">Irem Hacisalihoglu Aydin, MD</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/time-to-think-of-aggression-as-a-treatment-target-symptom-independent-of-diagnosis?utm_source=www.psychiatrictimes.com&utm_medium=relatedContent"></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 gap-x-4"><a class="jsx-ad50481d5ee26850" href="/view/positive-phase-3-results-evaluating-lumateperone-for-the-prevention-of-relapse-in-schizophrenia?utm_source=www.psychiatrictimes.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/psychtimes/aa32b9c9311ae9016ca84e15914daf1d3645a569-6272x3584.jpg?fit=crop&auto=format" alt="schizophrenia" width="288" class="jsx-ad50481d5ee26850 lg:w-[110px] lg:h-[100px] xl:w-[135px] xl:h-[125px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full xl:w-[70%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 6th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/positive-phase-3-results-evaluating-lumateperone-for-the-prevention-of-relapse-in-schizophrenia?utm_source=www.psychiatrictimes.com&utm_medium=relatedContent">Positive Phase 3 Results Evaluating Lumateperone for the Prevention of Relapse in Schizophrenia</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/leah-kuntz">Leah Kuntz</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/positive-phase-3-results-evaluating-lumateperone-for-the-prevention-of-relapse-in-schizophrenia?utm_source=www.psychiatrictimes.com&utm_medium=relatedContent"></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div></div></div></div><div class="pb-24"></div></div><script type="application/ld+json">{"@context":"https://schema.org","@type":"NewsArticle","headline":"ADHD in Older Adults","datePublished":"2016-08-15T20:13:35Z","dateModified":"2020-11-16T03:04:29Z","inLanguage":"en-US","image":"https://cdn.sanity.io/images/0vv8moc6/psychtimes/0566cbf15de9d5cd6f9e2ddb91aa6037d0b1d35c-1000x604.jpg?fit=crop&auto=format","mainEntityOfPage":{"@type":"WebPage","@id":"https://www.psychiatrictimes.com/view/adhd-older-adults"},"publisher":{"@type":"Organization","name":"Psychiatric Times","logo":{"@type":"ImageObject","url":"https://www.psychiatrictimes.com/PsychiatricTimesLogo.png"}},"keywords":"ADHD,Psychopharmacology","articleBody":"\n\n\n\n \n\nFor which patients over 50 who complain of cognitive difficulty should ADHD be considered in the differential? What are the treatment options for older adults with this diagnosis? David Goodman, MD, FAPA addresses both questions in this brief podcast.\n\nDr Goodman is Assistant Professor of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine. He is also Director of the Adult Attention Deficit Disorder Center of Maryland in Lutherville, and Director of Suburban Psychiatric Associates, LLC.\n\nA principal investigator for multi-site Phase II and III drug trials for the treatment of adult ADHD and major depression, Dr Goodman is the lead author on the largest published adult ADHD trial. He is also lead author on the largest survey assessment of physician clinical practice for adults with ADHD.\n\nDiscussed in this podcast:\n\nClinical Presentation, Diagnosis and Treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in Older Adults: A Review of the Evidence and its Implications for Clinical Care.\n\nQuality of Life in Adults Aged 50+ With ADHD\n\nPsychopharmacological Treatment of ADHD in Adults Aged 50+: An Empirical Study\n\nPrevalence of Attention-Deficit Hyperactivity Disorder in Older Adults in The Netherlands\n\nThe Identification and Assessment of Late-Life ADHD in Memory Clinics","description":"An expert discusses ADHD in patients over 50.","author":[{"@type":"Person","name":"David W. Goodman, MD"}]}</script></div></div><div class="flex-none w-[300px] z-[9999] relative hidden md:block"><div style="top:5rem" class="sticky custom-spacing"><div class="collapse-container " style="overflow:hidden;max-height:900px;transition:max-height .4s ease-in-out"></div></div></div></div><div id="div-gpt-ad-pixel" style="width:1px;height:1px" class=""></div><noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-5V9L5PL" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript><div id="footerOuterWrap" class="w-full bg-primary flex flex-col items-center justify-center"><div class="container w-[1340px]"><div id="footerInnerWrap" class="bg-primary w-full py-12"><div class="py-4 pl-4 flex flex-row items-center"><div class="flex flex-row flex-wrap w-[55%] h-full"><div class="w-[33%] p-1 my-0 cursor-pointer text-footer-text-color hover:text-footer-text-color/80 hover:underline"><a class="text-md" target="_self" href="/about">About</a></div><div 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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. 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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","style":"normal"},{"children":[{"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":[]},{"marks":["superscript"],"text":"4","_key":"2cd84761ed9c","_type":"span"},{"_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? 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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"},{"_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.","_key":"fddf3b368355"}],"_type":"block","style":"normal","_key":"84c0e2ff246f","markDefs":[]},{"children":[{"_type":"span","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","marks":["superscript"],"text":"3","_key":"30ea0ef1ce7f"}],"_type":"block","style":"normal","_key":"7fac76e86563","markDefs":[]},{"_type":"block","style":"normal","_key":"14e6ebfe8a30","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Repurposing Metformin","_key":"aa9a379177900"}]},{"markDefs":[],"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"},{"text":"4","_key":"f1cb215206b1","_type":"span","marks":["superscript"]},{"_type":"span","marks":[],"text":" It is widely recognized that metformin improves hyperglycemia and insulin sensitivity.","_key":"f1e0932e8960"},{"_type":"span","marks":["superscript"],"text":"4","_key":"975b9db5a95e"},{"_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"},{"_key":"3737df516fee","_type":"span","marks":[],"text":" and is associated with T2D, dementia, cancer, and cardiovascular disease."},{"_type":"span","marks":["superscript"],"text":"6","_key":"7b5b5e24bc18"},{"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","_type":"span","marks":[]},{"_key":"ed81224bc2e0","_type":"span","marks":["superscript"],"text":"7"},{"_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"},{"_key":"851909c44ac8","_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."}],"_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"},{"_type":"span","marks":["superscript"],"text":"5","_key":"0f9339c87b3d"},{"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","_type":"span"},{"_type":"span","marks":["superscript"],"text":"5","_key":"eac32f92cac5"},{"_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"},{"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","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"3,5","_key":"536d6ccc4c78"},{"_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"},{"_type":"span","marks":[],"text":" Metformin may also mimic the geroprotective effects of exercise.","_key":"acda869d7c33"},{"_key":"75b714e72f29","_type":"span","marks":["superscript"],"text":"5"},{"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"},{"_type":"span","marks":["superscript"],"text":"3","_key":"0c81f29f4808"}],"_type":"block","style":"normal","_key":"898f9e41d9ea"},{"_key":"6f4731648f18","markDefs":[],"children":[{"marks":["strong"],"text":"Reducing Inflammation","_key":"ba9f35da59e00","_type":"span"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"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","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"11","_key":"9a83f83e277c"},{"_key":"4eda992e53e0","_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 "},{"_type":"span","marks":["em"],"text":"inflammaging","_key":"a4950ba0a33f"},{"_type":"span","marks":[],"text":", that originates in the gut.","_key":"adcc3daab207"},{"marks":["superscript"],"text":"11","_key":"a4b5af286d03","_type":"span"},{"_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"},{"_type":"span","marks":["em"],"text":"leaky gut","_key":"971f33dbd4a2"},{"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","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"12","_key":"a3a5b907b15c"}],"_type":"block","style":"normal","_key":"f55f70c04179"},{"children":[{"_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.","_key":"800a366150060"},{"text":"12","_key":"0cfb1a6c1850","_type":"span","marks":["superscript"]},{"_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"},{"_type":"span","marks":["superscript"],"text":"5","_key":"67df2baf9e08"},{"marks":[],"text":" For example, autophagy (a cellular recycling program that removes dysfunctional organelles from the cytoplasm) deteriorates with aging.","_key":"848a603bb9aa","_type":"span"},{"_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"},{"text":"5","_key":"4c3a8e06e572","_type":"span","marks":["superscript"]},{"_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.","_key":"87babbf490d0"},{"_type":"span","marks":["superscript"],"text":"3","_key":"13fcb52d2b7a"}],"_type":"block","style":"normal","_key":"295d9b8efc6a","markDefs":[]},{"markDefs":[],"children":[{"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"},{"_key":"f54b4bf052cb","_type":"span","marks":["superscript"],"text":"3"},{"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":[]},{"_type":"span","marks":["superscript"],"text":"13","_key":"b0f481c886b3"},{"_type":"span","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"},{"marks":["superscript"],"text":"6,13","_key":"cd57411e06fd","_type":"span"}],"_type":"block","style":"normal","_key":"4cf19120eca8"},{"_key":"73a7f73e6d72","markDefs":[],"children":[{"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":[]},{"marks":["superscript"],"text":"3","_key":"46ca5b922f64","_type":"span"},{"_type":"span","marks":[],"text":" The end result was a decrease in plasma glucose and decreased insulin resistance.","_key":"62ede7391789"},{"marks":["superscript"],"text":"3","_key":"1cf738f968c6","_type":"span"},{"_type":"span","marks":[],"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":["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":[]},{"_type":"span","marks":["superscript"],"text":"14","_key":"7197224f33b9"},{"_type":"span","marks":[],"text":" The gut microbiota is an ecosystem that interacts in a symbiotic fashion with the host to promote health.","_key":"f761270411f9"},{"_type":"span","marks":["superscript"],"text":"15","_key":"a98ecdd92b2a"},{"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"},{"_type":"span","marks":["superscript"],"text":"15","_key":"6d1fcfac8007"},{"marks":[],"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"},{"_type":"span","marks":["superscript"],"text":"11","_key":"3079a4a577f2"},{"_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).","_key":"23e7c8cef248"},{"_type":"span","marks":["superscript"],"text":"16","_key":"35627fe68f52"},{"_type":"span","marks":[],"text":" These bacteria ferment dietary carbohydrates that humans cannot digest.","_key":"057002cfde4b"},{"_key":"14fc4a784ada","_type":"span","marks":["superscript"],"text":"16"},{"text":" SCFAs are widely known for enhancing glucose homeostasis in adipose tissue, liver, and muscles.","_key":"f988f93121f3","_type":"span","marks":[]},{"marks":["superscript"],"text":"16","_key":"8fb2600e6096","_type":"span"},{"_key":"81a0e45c8014","_type":"span","marks":[],"text":" Metformin also reduces the abundance of proinflammatory bacterial species supporting the integrity of the intestinal barrier."},{"_type":"span","marks":["superscript"],"text":"12","_key":"eb4abd61b50c"},{"_type":"span","marks":[],"text":" In animal studies, metformin expanded the gut population of ","_key":"cc75fa8c9558"},{"text":"Akkermansia","_key":"a6167e8d3934","_type":"span","marks":["em"]},{"_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"},{"_type":"block","style":"normal","_key":"4fb1300d4915","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Anticancer Effects","_key":"5f2cc84aaeb60"}]},{"style":"normal","_key":"fa3b304ce712","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"},{"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","_type":"span"},{"_type":"span","marks":[],"text":" Whether metformin can delay the onset of other age-associated cancer and pathology remains unclear.","_key":"a0bf1b68d57b"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Neuroprotective Effects","_key":"f20573a7f2b40"}],"_type":"block","style":"normal","_key":"6b26c11ddbc0"},{"_type":"block","style":"normal","_key":"dedc390636a7","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"},{"_type":"span","marks":["superscript"],"text":"17","_key":"7af7604a4b66"},{"_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?","_key":"f6141d94acda"}]},{"_key":"0a36ebb4e75f","markDefs":[],"children":[{"_type":"span","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","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"},{"_type":"span","marks":["superscript"],"text":"18","_key":"b13dfd23b892"}],"_type":"block","style":"normal"},{"children":[{"_type":"span","marks":["strong"],"text":"Concluding Thoughts","_key":"cbfdef33f8d50"}],"_type":"block","style":"normal","_key":"e7a3e448ff05","markDefs":[]},{"markDefs":[],"children":[{"text":"In sum, the repurposing of metformin has been of research and clinical interest worldwide. Interest in metformin’s potential benefits in aging-related diseases has been renewed given the increase in human life span and the need to extend quality of life in geriatric populations. Despite promising data from preclinical and observational studies, the use of metformin for antiaging continues to be investigational. Whether geroprotection will become another avatar of metformin remains to be seen.","_key":"b05a01dd20e40","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"652263f9a7cc"},{"markDefs":[],"children":[{"_key":"d37e11def5620","_type":"span","marks":["strong"],"text":"Dr Modesto-Lowe"},{"_type":"span","marks":[],"text":" ","_key":"a89fe7ef3c7f"},{"marks":["em"],"text":"is medical director at Hartford Behavioral Health and community faculty at the University of Connecticut. ","_key":"575ab1288c9f","_type":"span"},{"_type":"span","marks":["strong"],"text":"Dr León-Barriera","_key":"63ce04ebfa4b"},{"_key":"460b92c492a0","_type":"span","marks":[],"text":" "},{"text":"is an assistant professor of psychiatry at the University of Pittsburgh School of Medicine in Pennsylvania.","_key":"732108c5419c","_type":"span","marks":["em"]},{"_key":"52c34c5d664f","_type":"span","marks":[],"text":" "},{"_type":"span","marks":["strong"],"text":"Dr Kaur","_key":"f5d1e876305d"},{"_type":"span","marks":["em"],"text":" is a principal psychiatrist at the Connecticut Valley Hospital in Middletown.","_key":"887cde5be847"}],"_type":"block","style":"normal","_key":"8694ff4d405a"},{"style":"normal","_key":"f18ede3b023b","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"References","_key":"c8b6cfb164660"}],"_type":"block"},{"markDefs":[{"href":"https://www.ccjm.org/content/90/9/523","_key":"651e51b33902","nofollow":true,"blank":true,"_type":"link"}],"children":[{"_type":"span","marks":[],"text":"1. Mandell BF. ","_key":"24080cdd9f440"},{"_type":"span","marks":["651e51b33902"],"text":"Born again: the many lives of metformin.","_key":"0bfa7b823b48"},{"text":" ","_key":"9f97cce5394c","_type":"span","marks":[]},{"_type":"span","marks":["em"],"text":"Cleve Clin J Med","_key":"13f930faa29f"},{"marks":[],"text":". 2023;90(9):523-524.","_key":"99f7d2afe041","_type":"span"}],"_type":"block","style":"normal","_key":"eff0856c7f5a"},{"children":[{"_type":"span","marks":[],"text":"2. Ban TA. ","_key":"f66d710dc8e60"},{"marks":["de3e02566b86"],"text":"Fifty years chlorpromazine: a historical perspective.","_key":"b0d063451902","_type":"span"},{"_type":"span","marks":[],"text":" ","_key":"fba200964924"},{"_key":"24fbf556c0f4","_type":"span","marks":["em"],"text":"Neuropsychiatr Dis Treat"},{"marks":[],"text":". 2007;3(4):495-500.","_key":"0b9c4f7596a1","_type":"span"}],"_type":"block","style":"normal","_key":"3e6424f9561d","markDefs":[{"nofollow":true,"blank":true,"_type":"link","href":"https://pmc.ncbi.nlm.nih.gov/articles/PMC2655089/","_key":"de3e02566b86"}]},{"_type":"block","style":"normal","_key":"d8f7e7b7371a","markDefs":[{"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/32333835/","_key":"94b0da9b30f5","nofollow":true,"blank":true}],"children":[{"text":"3. Kulkarni AS, Gubbi S, Barzilai N. ","_key":"942a95d426320","_type":"span","marks":[]},{"text":"Benefits of metformin in attenuating the hallmarks of aging. ","_key":"fa4ff146884a","_type":"span","marks":["94b0da9b30f5"]},{"_key":"0d7a8913f290","_type":"span","marks":["em"],"text":"Cell Metab"},{"_type":"span","marks":[],"text":". 2020;32(1):15-30.","_key":"8eacd8cf8b88"}]},{"markDefs":[{"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/33808194/","_key":"518132438d38","nofollow":true,"blank":true}],"children":[{"_type":"span","marks":[],"text":"4. Lee CB, Chae SU, Jo SJ, et al. ","_key":"746695cd52170"},{"_type":"span","marks":["518132438d38"],"text":"The relationship between the gut microbiome and metformin as a key for treating type 2 diabetes mellitus.","_key":"2c39d81038db"},{"_type":"span","marks":[],"text":" ","_key":"e31c8442a750"},{"_type":"span","marks":["em"],"text":"Int J Mol Sci.","_key":"3f8fde30690e"},{"_type":"span","marks":[],"text":" 2021;22(7):3566.","_key":"25c09e9f896f"}],"_type":"block","style":"normal","_key":"d70d35cf4907"},{"_key":"78d602565de5","markDefs":[{"href":"https://pubmed.ncbi.nlm.nih.gov/36077358/","_key":"98f2286b98bf","nofollow":true,"blank":true,"_type":"link"}],"children":[{"_type":"span","marks":[],"text":"5. De Sousa Lages A, Lopes V, Horta J, et al. ","_key":"f90e797651ac0"},{"text":"Therapeutics that can potentially replicate or augment the anti-aging effects of physical exercise.","_key":"7e9dedcfa10c","_type":"span","marks":["98f2286b98bf"]},{"_type":"span","marks":[],"text":" ","_key":"4e2a01f4f48e"},{"_type":"span","marks":["em"],"text":"Int J Mol Sci","_key":"7582a2dc7ebd"},{"_type":"span","marks":[],"text":". 2022;23(17):9957.","_key":"28dc3a1e1dbe"}],"_type":"block","style":"normal"},{"_key":"75794cfc98f3","markDefs":[{"_key":"b3da78601e7c","nofollow":true,"blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/32905803/"}],"children":[{"_type":"span","marks":[],"text":"6. Zajda A, Huttunen KM, Sikora J, et al. ","_key":"4bd36f1959bb0"},{"text":"Is metformin a geroprotector? A peek into the current clinical and experimental data.","_key":"4728e6098d40","_type":"span","marks":["b3da78601e7c"]},{"_type":"span","marks":[],"text":" ","_key":"1ac654a19992"},{"_type":"span","marks":["em"],"text":"Mech Ageing Dev","_key":"7a9ea5082446"},{"_type":"span","marks":[],"text":". 2020;191:111350.","_key":"03ec009c4c37"}],"_type":"block","style":"normal"},{"_key":"4e23412f1577","markDefs":[{"_key":"114354fe97fc","nofollow":true,"blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/9742977/"}],"children":[{"_type":"span","marks":[],"text":"7. UK Prospective Diabetes Study (UKPDS) Group. ","_key":"bfc4cd4655c30"},{"_type":"span","marks":["114354fe97fc"],"text":"Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34).","_key":"77df67a3245a"},{"_type":"span","marks":[],"text":" ","_key":"50838b5379c4"},{"marks":["em"],"text":"Lancet","_key":"0aebd5c55744","_type":"span"},{"_type":"span","marks":[],"text":". 1998;352(9351):854-865.","_key":"f3f88760751e"}],"_type":"block","style":"normal"},{"markDefs":[{"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/28802803/","_key":"264419501f1a","nofollow":true,"blank":true}],"children":[{"_type":"span","marks":[],"text":"8. Campbell JM, Bellman SM, Stephenson MD, Lisy K. ","_key":"cdfef49bae770"},{"marks":["264419501f1a"],"text":"Metformin reduces all-cause mortality and diseases of ageing independent of its effect on diabetes control: a systematic review and meta-analysis.","_key":"464f701792a5","_type":"span"},{"_type":"span","marks":[],"text":" ","_key":"368203c84641"},{"_type":"span","marks":["em"],"text":"Ageing Res Rev","_key":"988d31f44014"},{"_type":"span","marks":[],"text":". 2017;40:31-44.","_key":"997039133902"}],"_type":"block","style":"normal","_key":"d94f22570a59"},{"children":[{"_key":"280e8daece830","_type":"span","marks":[],"text":"9. Hua Y, Zheng Y, Yao Y, et al. 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Today, we will address 4 of them.","_key":"71338ce3cff21"}],"_type":"block","style":"normal","_key":"be5283bf4499","markDefs":[]},{"_key":"34fc570ee2b6","markDefs":[],"children":[{"_key":"e9fd90e430050","_type":"span","marks":[],"text":"Welcome to "},{"marks":["em"],"text":"PsychPearls","_key":"e9fd90e430051","_type":"span"},{"text":" podcast with ","_key":"e9fd90e430052","_type":"span","marks":[]},{"marks":["em"],"text":"Psychiatric Times","_key":"e9fd90e430053","_type":"span"},{"_type":"span","marks":["superscript"],"text":"TM","_key":"e9fd90e430054"},{"_type":"span","marks":[],"text":", the voice of psychiatry. With thoughtful insights into the world of mental health, this podcast provides timely clinical commentary and practical cutting-edge pearls for you and your practice. We hope you enjoy it.","_key":"55b4e2909f49"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"308fc4380485","markDefs":[],"children":[{"_type":"span","marks":[],"text":"I am Chris Aiken, the Mood Disorders Section Editor for ","_key":"ea53b84443740"},{"marks":["em"],"text":"Psychiatric Times","_key":"ea53b84443741","_type":"span"},{"_type":"span","marks":["superscript"],"text":"TM","_key":"ea53b84443742"},{"text":" and the editor-in-chief of the ","_key":"2a1d567b6175","_type":"span","marks":[]},{"_type":"span","marks":["em"],"text":"Carlat Psychiatry Report","_key":"ea53b84443743"},{"_type":"span","marks":[],"text":", and I am Kellie Newsome, a psychiatric NP and the cohost of the ","_key":"ea53b84443744"},{"_type":"span","marks":["em"],"text":"Carlat Psychiatry Podcast","_key":"ea53b84443745"},{"_type":"span","marks":[],"text":".","_key":"ea53b84443746"}]},{"_type":"block","style":"normal","_key":"9e73ca7194e2","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"A Quiet Launch","_key":"86ea5d507ff30"}]},{"children":[{"_type":"span","marks":["strong"],"text":"KELLIE NEWSOME:","_key":"afec8962a0580"},{"_type":"span","marks":[],"text":" On June 20, 2003, the world had its eyes on the United States’ invasion of Iraq. Some of us were following Martha Stewart’s indictment for insider trading, and quite a few were lining up at bookstores to be the first to buy the 5th installment in the Harry Potter series. But Russell Katz, MD, was busy at his desk on this day at the US Food and Drug Administration (FDA) headquarters, writing a letter to GlaxoSmithKline announcing the approval of their anticonvulsant lamotrigine in bipolar disorder. But the approval was not a slam-dunk. GlaxoSmithKline had submitted 12 trials, and only 2 of them were positive. Lamotrigine did not work in acute mania; it did not work in acute bipolar depression; and it did not work in rapid cycling.","_key":"afec8962a0581"}],"_type":"block","style":"normal","_key":"a63f35be65e5","markDefs":[]},{"_key":"c0eb9ce72ebb","markDefs":[],"children":[{"_type":"span","marks":[],"text":"But bipolar disorder (BD) is a chronic condition, and that is where the medication succeeded: in the maintenance phase.","_key":"9d8e4fd3af040"}],"_type":"block","style":"normal"},{"children":[{"marks":[],"text":"The 2 positive studies looked at lamotrigine in the long term, over 1 and a half years. There, lamotrigine helped patients stay well about twice as long as a placebo.","_key":"64d6e68df2480","_type":"span"},{"_key":"73fb7856ebbe","_type":"span","marks":["superscript"],"text":"1"},{"text":" Katz knew that long-term studies like this were expensive and hard to come by, but for patients who have to stay on a mood stabilizer year after year it is this kind of data that matters most. So he gave it an indication for delaying new episodes of depression, hypomania, and mania in BD.","_key":"5db9d5a360d0","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"2b3bbb539720","markDefs":[]},{"_type":"block","style":"normal","_key":"184030a32757","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"CHRIS AIKEN:","_key":"e07cb217d3d60"},{"_type":"span","marks":[],"text":" And that is how lamotrigine was launched. But there are a lot of loose threads in that story that have tangled into myths, and today we are going to unravel 4 of them so you can use lamotrigine more effectively in practice.","_key":"e07cb217d3d61"}]},{"children":[{"text":"A Warning","_key":"75b3c80a10a30","_type":"span","marks":["strong"]}],"_type":"block","style":"normal","_key":"233f91ee925a","markDefs":[]},{"_key":"7117c4dbf031","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"CHRIS AIKEN:","_key":"3959c05423550"},{"_type":"span","marks":[],"text":" But first a warning. Lamotrigine is not a panacea. It works in BD, but it does not treat non-bipolar depression. There the studies are mixed: half positive, half negative. It has positive controlled trials in obsessive compulsive disorder, borderline personality disorder, and depersonalization disorder, but those studies are few and small.","_key":"3959c05423551"},{"_type":"span","marks":["superscript"],"text":"2","_key":"0fbe71658c79"},{"_type":"span","marks":[],"text":" So do not start prescribing lamotrigine to every moody individual you see, because this medicine has one big risk that makes those uncharted adventures unwise: the potentially fatal rash of Stevens Johnson Syndrome.","_key":"ed9d37b2069d"}],"_type":"block","style":"normal"},{"children":[{"_type":"span","marks":[],"text":"That rash is part of the reason that lamotrigine had such a soft launch. Early on, the manufacturer decided not to market lamotrigine to primary care practices, and to minimize direct to consumer advertising. The decision may have hurt their quarterly profits, but it helped them stay in the market. You see, lamotrigine was nearly yanked off the market after its launch in epilepsy 10 years earlier. Back then, doctors were starting the drug at 100mg a day, which lead to an alarming rise in potentially fatal Stevens Johnson rashes. The medication only survived when the company was able to show that it could lower this risk through the slow titrations that we use today. Now that risk is around 1 in 3000.","_key":"1fb3158d8fbb0"},{"_type":"span","marks":["superscript"],"text":"3","_key":"8c34969f2243"}],"_type":"block","style":"normal","_key":"0d9d3c0fa520","markDefs":[]},{"markDefs":[],"children":[{"text":"GlaxoSmithKline was concerned that if they overhyped the drug, then clinicians with little experience in BD would prescribe it to every moody patient they saw, and if they overlooked the DSM in that way they might also overlook the titration instructions, causing a second flare of serious rashes that would cause the FDA to pull the plug again.","_key":"3a799e7b28970","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"c81541e1df53"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"KELLIE NEWSOME:","_key":"6fbf95ee9eec0"},{"text":" And now let us get into those myths. There are 4 of them.","_key":"6fbf95ee9eec1","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"fc3dcfb76df8"},{"_type":"block","style":"normal","_key":"842419cc5dfe","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Myth #1: Lamotrigine does not help mania","_key":"9731eb6e18c90"}]},{"style":"normal","_key":"28425af347c4","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Myth #2: Lamotrigine does not treat acute episodes of bipolar depression","_key":"1d6c4971e1980"}],"_type":"block"},{"_key":"90e174ac7e84","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Myth #3: Lamotrigine is a weak mood stabilizer","_key":"a2875e7deb100"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Myth #4: It is a good idea to stop lamotrigine when a patient relapses, because it is probably not working","_key":"1cc4573623ed0"}],"_type":"block","style":"normal","_key":"fa86dd8111b0"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Myth #1: Lamotrigine Does not Help Mania","_key":"6e5992c2c46f0"}],"_type":"block","style":"normal","_key":"eb46f4b7a0af"},{"style":"normal","_key":"b38e681b0544","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"CHRIS AIKEN:","_key":"ae0762d35ea90"},{"_type":"span","marks":[],"text":" This one is kind of true. Lamotrigine failed in the acute mania trials, and nothing that we have learned about this drug in the 25 years since suggests that it has any role in acute mania. But lamotrigine does help prevent mania, although it is better at preventing bipolar depression than it is at preventing mania. What that means in practice is that you should not rely on it as the sole maintenance medication in patients with a history of severe mania, but it may be used as monotherapy in bipolar II disorder, where the depressions are more common and the manic symptoms brief and mild.","_key":"ae0762d35ea91"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"In fact, many bipolar experts see good results in cyclothymic patients, who cycle frequently between mild depression, hypomania, and mixed states. That observation only supported by open-label studies, but hey – there are zero controlled medication trials in cyclothymic disorder so that is as good as it gets.","_key":"8aa3f8afb5920"},{"_type":"span","marks":["superscript"],"text":"4,5","_key":"b9fcb60198b3"}],"_type":"block","style":"normal","_key":"3011d070f04a"},{"children":[{"_type":"span","marks":["strong"],"text":"Myth #2: Lamotrigine Does Treat Acute Episodes of Bipolar Depression","_key":"facc22eea3890"}],"_type":"block","style":"normal","_key":"bc02774e1673","markDefs":[]},{"_key":"16a54e6b696b","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"CHRIS AIKEN:","_key":"1512b45c33820"},{"marks":[],"text":" Among the 12 trials on Katz’s desk, 5 of them are good candidates for the most disappointing trials in the history of psychiatry. These were the 5 controlled trials in acute bipolar depression, all funded by the manufacturer, and all of them failed. The trials were never published, but most psychiatrists knew about them when lamotrigine was released, and it gave some of us the impression that lamotrigine was a weak mood stabilizer that barely got approved for an indication that was not at the top of the list for doctors or patients.","_key":"1512b45c33821","_type":"span"}],"_type":"block","style":"normal"},{"children":[{"marks":[],"text":"But we have since learned that lamotrigine does treat acute depression, it just takes a little longer than faster options like the atypical antipsychotics. The problem is that the early studies only lasted 7 weeks, and lamotrigine requires a slow titration that takes 4 to 6 weeks to reach a therapeutic level. Later, lamotrigine did prove efficacious for acute bipolar depression in 2 independently funded randomized placebo-controlled trials.","_key":"ad08da73d7b30","_type":"span"},{"_type":"span","marks":["superscript"],"text":"6,7","_key":"3f7f57eb6ddf"}],"_type":"block","style":"normal","_key":"5943f97d91b3","markDefs":[]},{"markDefs":[],"children":[{"marks":["strong"],"text":"KELLIE NEWSOME:","_key":"1672bd87395e0","_type":"span"},{"_type":"span","marks":[],"text":" Wait a minute. You are saying the industry sponsored trials were all negative but the independent ones were positive? That is a first.","_key":"1672bd87395e1"}],"_type":"block","style":"normal","_key":"0b93e13917dc"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"CHRIS AIKEN:","_key":"7bf5ca1291820"},{"_type":"span","marks":[],"text":" Yes, and the difference is that the independently sponsored trials gave lamotrigine a little more time. They lasted 8 to 12 weeks instead of 7 weeks. Also, lamotrigine was used as augmentation in these trials – in 1 it augmented lithium and the other quetiapine – but I think lamotrigine can work as monotherapy in acute depression and the real difference here was the timespan.","_key":"7bf5ca1291821"}],"_type":"block","style":"normal","_key":"80917ad9e22c"},{"_key":"c117b51331c0","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"KELLIE NEWSOME:","_key":"2d03b35c77350"},{"_type":"span","marks":[],"text":" One reason we think it works as monotherapy is that John Geddes, MD, FRCPsych, Joseph Calabrese, MD, and Guy Goodwin, DPhil, reanalyzed the original 5 negative trials in an independently funded meta-analysis.","_key":"2d03b35c77351"},{"marks":["superscript"],"text":"8","_key":"cb882e6e34a5","_type":"span"},{"_key":"ccbd5a89a36a","_type":"span","marks":[],"text":" They found that there was a positive signal in the original studies, but they were too small to detect it. When combined together, totaling 1072 participants, lamotrigine had a small effect, bringing about a meaningful response in 1 out of 11 participants. But hey, cariprazine got FDA approval in bipolar depression with the same number needed to treat, and lamotrigine’s efficacy only starts to build at that 7-week mark. If you use lamotrigine for acute depression, you will probably need to wait about a month and a half to see an effect, and, judging from the longer trials, those benefits are likely to keep building over the next 1 to 4 months."}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"2901ac965eb3","markDefs":[],"children":[{"text":"A common strategy then is to start lamotrigine with a faster-acting agent like an atypical antipsychotic, and then slowly taper off the antipsychotic as lamotrigine starts to kick in. This gives you the best of both worlds: lamotrigine has excellent tolerability over the long term, with a low risk of weight gain, fatigue, cognitive problems, sexual dysfunction, or any of the long-term medical problems that show up in the warnings for antipsychotics.","_key":"e869be0741ea0","_type":"span","marks":[]}]},{"markDefs":[],"children":[{"_key":"b8f816b9efef0","_type":"span","marks":["strong"],"text":"CHRIS AIKEN:"},{"_type":"span","marks":[],"text":" One risk we do not think about enough is stroke. Stroke is the #1 cause of death in bipolar disorder, and lamotrigine and lithium are the only mood stabilizers that do not increase the risk of stroke; all the others have some marks against them there.","_key":"b8f816b9efef1"},{"text":"9","_key":"d99521f436db","_type":"span","marks":["superscript"]},{"_type":"span","marks":[],"text":" I am going to get on a soap box for a minute here and argue that bipolar is not a mental disorder. It’s a physical disorder, and not just because the brain is a physical organ. Heart disease starts 10 to 15 years earlier in individuals with BD, and you can even detect cardiovascular changes in teens with bipolar. Lifestyle may play a part, but I think about all that adrenaline pumping through the veins during mania and mixed states. This is a whole-body illness, and we ought to be thinking about long-term morbidity and mortality when choosing a mood stabilizer, not just relieving acute symptoms.","_key":"ba95c9c01a78"}],"_type":"block","style":"normal","_key":"2629a4935e8d"},{"markDefs":[],"children":[{"text":"KELLIE NEWSOME","_key":"602738f0ff8b0","_type":"span","marks":["strong"]},{"_type":"span","marks":[],"text":": Are you off your soap box yet?","_key":"602738f0ff8b1"}],"_type":"block","style":"normal","_key":"e770fed2200f"},{"children":[{"_type":"span","marks":["strong"],"text":"CHRIS AIKEN:","_key":"c1859d28767c0"},{"_type":"span","marks":[],"text":" No, I have one more thing to say. The ","_key":"c1859d28767c1"},{"_type":"span","marks":["em"],"text":"DSM","_key":"c1859d28767c2"},{"_type":"span","marks":[],"text":" is often criticized for promoting biological psychiatry through its black-box, symptom check-list approach. But to me, it is not biological enough. You could read the whole book and walk away with little sense that these mental illnesses are wrecking havoc on the heart, the gastrointestinal tract, the immunologic and neuroendocrine systems. You would never get that sense from reading Harrison’s textbook of internal medicine.","_key":"c1859d28767c3"}],"_type":"block","style":"normal","_key":"d5851fb382bb","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"KELLIE NEWSOME:","_key":"69bc2c73c4fe0"},{"_type":"span","marks":[],"text":" OK, can we get back to lamotrigine now.","_key":"69bc2c73c4fe1"}],"_type":"block","style":"normal","_key":"281873e8c0d3"},{"style":"normal","_key":"1c2d625d230e","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Myth #3: Lamotrigine Is a Weak Mood Stabilizer","_key":"a045c4658a1e0"}],"_type":"block"},{"style":"normal","_key":"22b7dd918fb9","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"CHRIS AIKEN:","_key":"af6b65c916ab0"},{"_type":"span","marks":[],"text":" Yes, and that segues back to another myth about lamotrigine, which is that treatments that are slow to act are not strong ones. This is not how chronic diseases are approached in other medical specialties, which naturally take a long-term, disease-modifying view. You will never see a diabetes study that looks at change on a symptom check-list over 4 weeks. Or take hypertension. Clonidine lowers blood pressure right away, but most physicians prefer a thiazide for hypertension because it lowers the long-term risks of morbidity and mortality.","_key":"af6b65c916ab1"}],"_type":"block"},{"_type":"block","style":"normal","_key":"28aae8f32b92","markDefs":[],"children":[{"_key":"6dbec22f80e90","_type":"span","marks":[],"text":"Individuals with bipolar disorder die 10 years earlier on average, and not from suicide. Kellie, can you read the top causes of death in bipolar disorder"},{"_type":"span","marks":["superscript"],"text":"10","_key":"88e0210b2ee1"},{"text":":","_key":"6c7ff3169e66","_type":"span","marks":[]}]},{"style":"normal","_key":"5b8045ad2141","markDefs":[],"children":[{"text":"Stroke","_key":"cc0d7696d8210","_type":"span","marks":["em"]}],"_type":"block"},{"_type":"block","style":"normal","_key":"a334e977573d","markDefs":[],"children":[{"marks":["em"],"text":"Heart disease","_key":"279f0a7387960","_type":"span"}]},{"markDefs":[],"children":[{"text":"Cancer","_key":"fc3cd57353fe0","_type":"span","marks":["em"]}],"_type":"block","style":"normal","_key":"d478f377ef13"},{"_type":"block","style":"normal","_key":"e7d523a20836","markDefs":[],"children":[{"marks":["em"],"text":"Diabetes","_key":"f20c00c3b8e90","_type":"span"}]},{"children":[{"_type":"span","marks":["em"],"text":"Chronic obstructive pulmonary disease (COPD)","_key":"4e21580caa460"}],"_type":"block","style":"normal","_key":"93584cb57e2c","markDefs":[]},{"_type":"block","style":"normal","_key":"37211411d6f4","markDefs":[],"children":[{"text":"Pneumonia and influenza","_key":"6f7027a8179e0","_type":"span","marks":["em"]}]},{"children":[{"_type":"span","marks":["em"],"text":"Accidental injuries","_key":"bc3d2a45ab910"}],"_type":"block","style":"normal","_key":"31192940618e","markDefs":[]},{"_type":"block","style":"normal","_key":"5f68a3d04a0b","markDefs":[],"children":[{"text":"Suicide","_key":"af30477033fe0","_type":"span","marks":["em"]}]},{"_type":"block","style":"normal","_key":"3c9ab1d299ba","markDefs":[{"href":"https://pubmed.ncbi.nlm.nih.gov/28976944/","_key":"0fb886e1546c","blank":true,"_type":"link"},{"_key":"d41529e80f4d","blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/26394555/"}],"children":[{"_type":"span","marks":["strong"],"text":"CHRIS AIKEN:","_key":"c84f7e8587670"},{"marks":[],"text":" Right, so if you can find a mood stabilizer that reduces those risks, or at least does not increase them, that is golden. Lamotrigine is neutral on all of them, and ","_key":"c84f7e8587671","_type":"span"},{"_type":"span","marks":["0fb886e1546c"],"text":"lithium brings down","_key":"c84f7e8587672"},{"_type":"span","marks":[],"text":" most of them. Specifically, lithium lowers the risk of heart disease, ","_key":"c84f7e8587673"},{"_type":"span","marks":["d41529e80f4d"],"text":"stroke","_key":"c84f7e8587674"},{"_type":"span","marks":[],"text":", cancer, viral infections, and suicide.","_key":"c84f7e8587675"}]},{"children":[{"_key":"49567e5202790","_type":"span","marks":["strong"],"text":"KELLIE NEWSOME:"},{"_type":"span","marks":[],"text":" But we are getting a bit ahead of ourselves here. I mean, long-term medical risks are important when considering a mood stabilizer, but we also want something that prevents the episodes. Here we have an interesting finding from studies that have compared lithium and lamotrigine.","_key":"49567e5202791"},{"marks":["superscript"],"text":"1","_key":"ec60417890f9","_type":"span"},{"_type":"span","marks":[],"text":" Lithium offers better prevention against the manic side, while lamotrigine works better against the depressive side, so combining the 2 makes sense. And one study did that – the LamLit trial – and confirmed that there are indeed additional benefits to combining the 2.","_key":"0696b2340ef6"},{"_type":"span","marks":["superscript"],"text":"3","_key":"e33cb03a7664"}],"_type":"block","style":"normal","_key":"0c8384d790a6","markDefs":[]},{"style":"normal","_key":"836bb2d48eed","markDefs":[],"children":[{"text":"CHRIS AIKEN:","_key":"922aa9e34a480","_type":"span","marks":["strong"]},{"_key":"922aa9e34a481","_type":"span","marks":[],"text":" And that is the long-term perspective that we need to take when choosing a mood stabilizer. This does not come naturally in psychiatry. If you work in a hospital, insurance is pressuring you to get the patient better quickly, so lamotrigine is not going to be your go-to agent. And if you work in an outpatient office, ask yourself: When was the last time a patient came in saying “I’d like a medication to prevent bipolar disorder”? In psychiatry, we treat suffering, and our patients want something that will work quickly."}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"And that brings us to the fourth myth.","_key":"4208a7ebf9fb0"}],"_type":"block","style":"normal","_key":"2fecb70096c1"},{"_key":"498a1cd97284","markDefs":[],"children":[{"_key":"e18dfc91b8830","_type":"span","marks":["strong"],"text":"Myth #4: It Is a Good Idea to Stop Lamotrigine When a Patient Relapses, Because It Is Probably not Working"}],"_type":"block","style":"normal"},{"_key":"87a3bcf042c3","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"KELLIE NEWSOME:","_key":"e6e53933eaea0"},{"text":" In the maintenance trials, lamotrigine delayed the time to a new episode by 197 days, about half a year, vs 86 days or 3 months for placebo. So it is about twice as effective as placebo, but it does not provide 100% protection (no mood stabilizer does). In practice, here is what I tell patients when starting it:","_key":"e6e53933eaea1","_type":"span","marks":[]}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"text":"Lamotrigine’s going to have a slow build because you have to raise it slowly to prevent a serious rash. That means you’re going to feel better gradually over the next 1 to 2 months, but on the other hand you are not likely to have many side effects or medicated feelings. And that is a good thing because you are likely to need something long term to prevent mood problems, and this one does not have any major long-term risks. But keep in mind it is not going to prevent all mood episodes, but it will cut the rate of those episodes in half. So instead of having depression, say, every year, it may be every 2 years. But no medication does everything, and there is a lot you can do to raise those odds of success.","_key":"ccb544652fbd0","_type":"span","marks":[]}],"_type":"block","style":"blockquote","_key":"0027df6157f5"},{"children":[{"_type":"span","marks":[],"text":"Then I talk about behavioral strategies for bipolar and depression. If you are interested in that, we have a separate podcast for patients that teaches these strategies. Search for ","_key":"2befe2137c4f0"},{"_type":"span","marks":["em"],"text":"The Pocket Psychiatrist","_key":"2befe2137c4f1"},{"_type":"span","marks":[],"text":" in your podcast store.","_key":"2befe2137c4f2"}],"_type":"block","style":"normal","_key":"adc73736bb44","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"CHRIS AIKEN:","_key":"6413e50b25ef0"},{"marks":[],"text":" A common mistake is to stop lamotrigine when an episode returns, which is a bit like stopping blood pressure and cholesterol medications because a patient had a heart attack. Lamotrigine’s most robust effects are in prevention, and prevention is difficult to measure in psychiatry. You would need a before-and-after mood chart to confirm that the medication is lowering the frequency of episodes as it promises to do. Even then the work is difficult because so many other factors can make mood better or worse. What I look for is improvement in the first 3 to 6 months after starting lamotrigine. If a patient stops it, I watch for worsening over the next 3 to 6 months. And I also listen for something that I have heard a lot of patients say on this medication, particularly those with the frequent ups and downs of cyclothymic disorder.","_key":"6413e50b25ef1","_type":"span"}],"_type":"block","style":"normal","_key":"0bae815f4e09"},{"style":"normal","_key":"2cc02bd19ecc","markDefs":[],"children":[{"text":"KELLIE NEWSOME:","_key":"b02c937742660","_type":"span","marks":["strong"]},{"text":" What is that?","_key":"b02c937742661","_type":"span","marks":[]}],"_type":"block"},{"_type":"block","style":"normal","_key":"29ed580449f0","markDefs":[{"href":"https://pubmed.ncbi.nlm.nih.gov/18402630/","_key":"3c66a7c96c61","blank":true,"_type":"link"},{"_key":"230edd4b803d","blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/20846461/"},{"blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/29944976/","_key":"b9eb677aeb0e"}],"children":[{"text":"CHRIS AIKEN:","_key":"db377cc4db680","_type":"span","marks":["strong"]},{"text":" They say they still feel the same about whatever problems they were having in life, but the feelings are less overwhelming. They see things in perspective better. And that matches up with what we see in neuroimaging studies of lamotrigine. The ","_key":"db377cc4db681","_type":"span","marks":[]},{"_key":"db377cc4db682","_type":"span","marks":["3c66a7c96c61"],"text":"amygdala"},{"_type":"span","marks":[],"text":" is less reactive to emotionally disturbing images, there is a rise in brain-strengthening ","_key":"db377cc4db683"},{"_key":"db377cc4db684","_type":"span","marks":["230edd4b803d"],"text":"BDNF"},{"_type":"span","marks":[],"text":" in the amygdala and frontal lobes. Overall, there are volumetric changes in ","_key":"db377cc4db685"},{"_type":"span","marks":["b9eb677aeb0e"],"text":"both the amygdala","_key":"db377cc4db686"},{"_type":"span","marks":[],"text":", which react to emotional events, and the frontal lobes, which temper those emotions and help individuals see things in perspective.","_key":"db377cc4db687"}]},{"_type":"block","style":"normal","_key":"a0300ccfb78f","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"KELLIE NEWSOME:","_key":"93a934eb15090"},{"_type":"span","marks":[],"text":" That sounds like something we could all use.","_key":"93a934eb15091"}]},{"_key":"c2f1a26e12a2","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"CHRIS AIKEN: ","_key":"1642a9ca5c050"},{"_type":"span","marks":[],"text":"Hold it there! This medication is not for everyone, and those imaging studies were done in individuals with bipolar disorder.","_key":"1642a9ca5c051"}],"_type":"block","style":"normal"},{"_key":"69da7a7fb82b","markDefs":[],"children":[{"_key":"e6fe8654b7a60","_type":"span","marks":["strong"],"text":"KELLIE NEWSOME:"},{"_type":"span","marks":[],"text":" Always on your soapbox. We will be back with more practical updates on","_key":"e6fe8654b7a61"},{"marks":["em"],"text":" PsychPearls","_key":"262ca8fa1ffe2","_type":"span"},{"text":", and you can also catch us every Monday on the ","_key":"262ca8fa1ffe3","_type":"span","marks":[]},{"_type":"span","marks":["em"],"text":"Carlat Psychiatry Podcast","_key":"262ca8fa1ffe4"},{"_type":"span","marks":[],"text":".","_key":"262ca8fa1ffe5"}],"_type":"block","style":"normal"},{"children":[{"_key":"0b534c6e2a1b0","_type":"span","marks":["strong"],"text":"Chris Aiken, MD, "},{"_key":"0b534c6e2a1b1","_type":"span","marks":["em"],"text":"is the Mood Disorders Section Editor for Psychiatric Times"},{"marks":["superscript"],"text":"TM","_key":"8fcbc68e4e51","_type":"span"},{"_type":"span","marks":["em"],"text":", the Editor in Chief of ","_key":"b530b386d0da"},{"marks":["db58429202cd"],"text":"The Carlat Psychiatry Report,","_key":"0b534c6e2a1b2","_type":"span"},{"_type":"span","marks":["em"],"text":" and the director of the ","_key":"0adffcfb87da"},{"_type":"span","marks":["dda141651d02","em"],"text":"Mood Treatment Center.","_key":"0b534c6e2a1b4"},{"text":" He has written several books on mood disorders, most recently","_key":"0b534c6e2a1b5","_type":"span","marks":["em"]},{"_type":"span","marks":[],"text":" ","_key":"0b534c6e2a1b6"},{"_type":"span","marks":["cdfb453bc0d0"],"text":"The Depression and Bipolar Workbook","_key":"0b534c6e2a1b7"},{"_type":"span","marks":["em"],"text":".","_key":"0b534c6e2a1b8"},{"_type":"span","marks":[],"text":" ","_key":"0b534c6e2a1b9"},{"_type":"span","marks":["em"],"text":"He can be heard in the weekly","_key":"0b534c6e2a1b10"},{"_key":"0b534c6e2a1b11","_type":"span","marks":[],"text":" "},{"_type":"span","marks":["em","9796910de3a6","em"],"text":"Carlat Psychiatry Podcast","_key":"0b534c6e2a1b12"},{"_type":"span","marks":["em"],"text":" with his cohost Kellie Newsome, PMH-NP. The author does not accept honoraria from pharmaceutical companies but receives royalties from PESI for","_key":"0b534c6e2a1b13"},{"_key":"0b534c6e2a1b14","_type":"span","marks":[],"text":" "},{"_type":"span","marks":["830ca5e74bce"],"text":"The Depression and Bipolar Workbook","_key":"0b534c6e2a1b15"},{"marks":["em"],"text":" and from W.W. Norton \u0026 Co. for","_key":"b3f080aec131","_type":"span"},{"marks":[],"text":" ","_key":"0b534c6e2a1b17","_type":"span"},{"_key":"0b534c6e2a1b18","_type":"span","marks":["ceb3d45c1ef0"],"text":"Bipolar, Not So Much"},{"_type":"span","marks":["em"],"text":". ","_key":"0b534c6e2a1b19"},{"_key":"0b534c6e2a1b20","_type":"span","marks":["strong"],"text":"Kellie L. Newsome, PMH-NP"},{"text":", is the cohost of the","_key":"0b534c6e2a1b21","_type":"span","marks":["em"]},{"text":" ","_key":"0b534c6e2a1b22","_type":"span","marks":[]},{"_type":"span","marks":["em"],"text":"Carlat Psychiatry Podcast","_key":"0b534c6e2a1b23"},{"_type":"span","marks":[],"text":" ","_key":"0b534c6e2a1b24"},{"_type":"span","marks":["em"],"text":"and is also a practicing psychiatric mental health nurse practitioner in Winston Salem, NC, at the Mood Treatment Center. 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Specifically, the likelihood for aggressive behaviors after study entry was significantly lower for clozapine (17.5%) vs olanzapine (23.1%), risperidone 24.4%, and haloperidol (45.9%)."},{"_key":"573babd98c86","_type":"span","marks":["superscript"],"text":"29"},{"_type":"span","marks":[],"text":" Measured aggression was significantly less likely to happen with clozapine than haloperidol (physical aggression: odds ration [OR] = 2.04, ","_key":"d8d825f0d457"},{"marks":["em"],"text":"P","_key":"4f1ea9f10ba91","_type":"span"},{"_type":"span","marks":[],"text":" \u003c 0.001, aggression against property: OR = 1.85, ","_key":"4f1ea9f10ba92"},{"_type":"span","marks":["em"],"text":"P ","_key":"4f1ea9f10ba93"},{"_type":"span","marks":[],"text":"\u003c 0.001, and verbal aggression: OR = 1.35, ","_key":"4f1ea9f10ba94"},{"_type":"span","marks":["em"],"text":"P","_key":"4f1ea9f10ba95"},{"text":" \u003c 0.001), and olanzapine (physical aggression: OR = 1.33, ","_key":"4f1ea9f10ba96","_type":"span","marks":[]},{"_type":"span","marks":["em"],"text":"P","_key":"4f1ea9f10ba97"},{"marks":[],"text":" \u003c 0.001, and verbal aggression: OR = 1.32, ","_key":"4f1ea9f10ba98","_type":"span"},{"text":"P","_key":"4f1ea9f10ba99","_type":"span","marks":["em"]},{"_type":"span","marks":[],"text":" \u003c 0.001, but not aggression against property: OR = 1.10, ","_key":"4f1ea9f10ba910"},{"_type":"span","marks":["em"],"text":"P","_key":"4f1ea9f10ba911"},{"text":" = 0.78) (risperidone not examined in this study).","_key":"4f1ea9f10ba912","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"31","_key":"c0c11ee63496"},{"_type":"span","marks":[],"text":" In this same study, olanzapine was also superior to haloperidol (physical aggression: OR = 1.54, ","_key":"d9e725babbc5"},{"_type":"span","marks":["em"],"text":"P","_key":"4f1ea9f10ba913"},{"_type":"span","marks":[],"text":" \u003c 0.001, aggression against property: OR 1.67, ","_key":"4f1ea9f10ba914"},{"_type":"span","marks":["em"],"text":"P","_key":"4f1ea9f10ba915"},{"_type":"span","marks":[],"text":" \u003c 0.001, but not verbal aggression: OR = 1.03, ","_key":"4f1ea9f10ba916"},{"_key":"4f1ea9f10ba917","_type":"span","marks":["em"],"text":"P"},{"_key":"4f1ea9f10ba918","_type":"span","marks":[],"text":" = 0.57)."},{"_type":"span","marks":["superscript"],"text":"31","_key":"afd58930ab29"},{"_key":"d9c34dad3298","_type":"span","marks":[],"text":" In a comparative study that examined the hostility items of the Positive and Negative Syndrome Scale (PANNS), clozapine was the only agent that significantly reduced measured hostility vs baseline ("},{"_type":"span","marks":["em"],"text":"P","_key":"4f1ea9f10ba919"},{"marks":[],"text":" = 0.019) and was superior to risperidone (","_key":"4f1ea9f10ba920","_type":"span"},{"_key":"4f1ea9f10ba921","_type":"span","marks":["em"],"text":"P"},{"_type":"span","marks":[],"text":" = 0.012) and haloperidol (","_key":"4f1ea9f10ba922"},{"_type":"span","marks":["em"],"text":"P","_key":"4f1ea9f10ba923"},{"_type":"span","marks":[],"text":" = 0.021) but not olanzapine.","_key":"4f1ea9f10ba924"},{"text":"30","_key":"eb78d086bbbb","_type":"span","marks":["superscript"]},{"marks":[],"text":" More importantly, this effect occurred at therapeutic dosageand was independent of clozapine’s antipsychotic effect or the occurrence of sedation.","_key":"88b5453583d6","_type":"span"},{"_type":"span","marks":["superscript"],"text":"25,30,31","_key":"ad512761051c"},{"_type":"span","marks":[],"text":" Clozapine is also effective in a genetic animal model of a developmental disorder (immediate early gene transcription factor, ","_key":"3cbb21b2832c"},{"_type":"span","marks":["em"],"text":"Egr3","_key":"4f1ea9f10ba925"},{"_type":"span","marks":[],"text":", knockout) in which the animals become aggressive.","_key":"4f1ea9f10ba926"},{"text":"32","_key":"6be8888079fe","_type":"span","marks":["superscript"]}],"_type":"block","style":"normal","_key":"d87b487caeda"},{"style":"normal","_key":"00d4ce674333","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"3d3a97be187f0"}],"_type":"block"},{"markDefs":[],"children":[{"text":"Similarly, asenapine has also demonstrated anti-aggression effects in a prospective study comparing asenapine with treatment as usual (TAU) for 48 patients who were admitted with significant aggression.","_key":"ba7b7c46b2d00","_type":"span","marks":[]},{"text":"33","_key":"3918cb318c12","_type":"span","marks":["superscript"]},{"text":" Asenapine was superior to TAU as measured by the Modified Overt Aggression Scale [MOAS]). There was a significant reduction physical aggression (–8.0 ± 5.06 vs. –0.78 ± 2.40, ","_key":"d73f8e497c24","_type":"span","marks":[]},{"marks":["em"],"text":"P","_key":"ba7b7c46b2d01","_type":"span"},{"marks":[],"text":" \u003c 0.0001), and total (–14.7 ± 11.59 vs. –5.4 ± 10.12, ","_key":"ba7b7c46b2d02","_type":"span"},{"_type":"span","marks":["em"],"text":"P","_key":"ba7b7c46b2d03"},{"_type":"span","marks":[],"text":" = 0.045) aggression as measured by the MOAS.33 More recently, a post hoc analysis of hostility in 442 patients with schizophrenia treated with a transdermal formulation of asenapine found that hostility item improved independent of antipsychotic effect and after correcting for covariates, indicating that the antihostility effect is independent of the antipsychotic effect.","_key":"ba7b7c46b2d04"},{"_type":"span","marks":["superscript"],"text":"34","_key":"ab7135cee003"},{"_key":"2df48b7fdf2b","_type":"span","marks":[],"text":" Sublingual asenapine has also demonstrated significant reductions in hostility, irritability, and disruptive behavior vs placebo in participants experiencing acute mania."},{"_type":"span","marks":["superscript"],"text":"35","_key":"154ff70deda8"},{"_type":"span","marks":[],"text":" Asenapine may be effective quickly and in a randomized, placebo-controlled study of agitation in a mixed diagnosis sample (schizophrenia, bipolar disorder, major depressive disorder, anxiety, and posttraumatic stress disorder) it significantly reduced the Excited Component of the Positive and Negative Syndrome Scale (PANSS-EC).","_key":"f2e7651e8fca"},{"_type":"span","marks":["superscript"],"text":"36","_key":"11e45dfdba77"},{"_key":"4bb32e731f21","_type":"span","marks":[],"text":" Adequate D4 blockade and the anti-aggression effect is likely achieved at 5 mg daily, whereas the minimum antipsychotic dose is 10 mg daily, and it is believed that aggression should improve at 5 mg."},{"_type":"span","marks":["superscript"],"text":"5","_key":"3ec839083c13"}],"_type":"block","style":"normal","_key":"42f4f44e7388"},{"children":[{"text":"","_key":"3eea52006e950","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"08bf5f62a753","markDefs":[]},{"_type":"block","style":"normal","_key":"6ba79cdf17c8","markDefs":[],"children":[{"_key":"b330f94e53490","_type":"span","marks":[],"text":"Loxapine is a second-generation antipsychotic agent that was not identified as such prior to the introduction of clozapine."},{"_type":"span","marks":["superscript"],"text":"37","_key":"bc4d83e703e2"},{"text":" It has a long history of treating aggression, hostility, and agitation in patients with bipolar disorder and schizophrenia experiencing acute mania and psychosis with both injectable","_key":"76a76069f4bc","_type":"span","marks":[]},{"_key":"2d0982906700","_type":"span","marks":["superscript"],"text":"38-40"},{"_key":"7e867f011f2e","_type":"span","marks":[],"text":" and inhalable formulations."},{"_key":"69daa13d0c7c","_type":"span","marks":["superscript"],"text":"41-43"},{"_type":"span","marks":[],"text":" Significantly, the effect on reducing aggression in agitated patients appears to occur independent of diagnosis.","_key":"3f6b315fac71"},{"_type":"span","marks":["superscript"],"text":"44","_key":"672477566378"},{"_type":"span","marks":[],"text":" Receptor occupancy is generally poorly studied in older medications, but the antipsychotic effect (ie, D2 receptor occupancy of 60% to 80%) probably occurs at 15 to 30 mg daily,","_key":"3051c231ba46"},{"_type":"span","marks":["superscript"],"text":"45","_key":"e20ed29c7dbc"},{"marks":[],"text":" and since the affinity at D4 is 3 times greater than at D2, one would expect that doses as low as 10 mg daily may be effective for aggression control.","_key":"d989c3c10ffe","_type":"span"}]},{"_type":"block","style":"normal","_key":"f5ed401d5cda","markDefs":[],"children":[{"text":"","_key":"e8d20c8ff0b60","_type":"span","marks":[]}]},{"_key":"832d49c169d7","markDefs":[{"nofollow":true,"blank":true,"_type":"link","href":"https://www.psychiatrictimes.com/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2Faa3baeda4703fa036fd74a42fbc01ad86c954b02-940x410.png%3Ffit%3Dcrop%26auto%3Dformat\u0026w=1920\u0026q=75","_key":"80bb7ee11446"},{"_key":"57e734fa5f24","nofollow":true,"blank":true,"_type":"link","href":"https://www.psychiatrictimes.com/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2Faa3baeda4703fa036fd74a42fbc01ad86c954b02-940x410.png%3Ffit%3Dcrop%26auto%3Dformat\u0026w=1920\u0026q=75"}],"children":[{"_type":"span","marks":[],"text":"Olanzapine and risperidone also have D4 affinities that exceeds D2 affinities (","_key":"b34326e935c90"},{"_type":"span","marks":["strong","57e734fa5f24"],"text":"Table","_key":"b34326e935c91"},{"_type":"span","marks":[],"text":").","_key":"b34326e935c92"},{"_type":"span","marks":["superscript"],"text":"20-22","_key":"329b377ebcc4"},{"_type":"span","marks":[],"text":" The difference is small but similar to asenapine (","_key":"afa2ed6dfb4f"},{"_type":"span","marks":["strong","80bb7ee11446"],"text":"Table","_key":"b34326e935c93"},{"text":").","_key":"b34326e935c94","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"20-22","_key":"4bdeee6e8eaa"},{"_type":"span","marks":[],"text":" For all 3 agents, it is likely that both receptors are blocked at doses that are frequently used. All these agents are frequently used in aggression because the drugs are approved for use in a wide range of psychiatric disorders. While asenapine has not been compared with clozapine, clozapine appears to be superior to both olanzapine and risperidone. Furthermore, reduction in aggression with olanzapine and risperidone appears to be related to their antipsychotic effect,","_key":"2d8e9cb2c0a2"},{"_type":"span","marks":["superscript"],"text":"29","_key":"e99a75e2e4fc"},{"text":" which does not appear to be the case for clozapine.","_key":"4a04c7674cad","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"29-31","_key":"3d2987dfd041"}],"_type":"block","style":"normal"},{"_key":"7367d4649dd6","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"c8dd077e91130"}],"_type":"block","style":"normal"},{"style":"normal","_key":"c7fa69c0b548","markDefs":[],"children":[{"marks":[],"text":"Some of these agents have affinity to D4 that exceeds the affinity for D2 (ie, affinity D4/affinity D2 \u003e 1).","_key":"cbd4828d00240","_type":"span"},{"_type":"span","marks":["superscript"],"text":"5","_key":"3e9c6be2d1be"},{"marks":[],"text":" Clozapine clearly has the best data and is likely superior to other agents.It is superior to risperidone, olanzapine, and haloperidol. It would appear that when a patient presents with aggression as an important symptom, targeting that symptom may have a greater impact than treating the underlying disease.","_key":"237e30e40ea7","_type":"span"}],"_type":"block"},{"_type":"block","style":"normal","_key":"bcbb3c6a0f0e","markDefs":[],"children":[{"_key":"fa4c62ae007a0","_type":"span","marks":[],"text":""}]},{"style":"normal","_key":"6f448b703d60","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Concluding Thoughts","_key":"beaa12fcd04d0"}],"_type":"block"},{"children":[{"_type":"span","marks":[],"text":"When aggression is the predominant clinical target symptom, agents with greater affinity to the D4 receptor vs the D2 receptor may be preferred. Clozapine, which has the greatest difference between the affinity to these 2 receptors, has been found to be superior in head-to-head studies. Furthermore, it appears that the efficacy of antipsychotic agents for aggression is related to the D4/D2 ratio, although the data are not adequate to be certain of this last point.","_key":"d75486bb76970"}],"_type":"block","style":"normal","_key":"5f2dc8c24cae","markDefs":[]},{"_type":"block","style":"normal","_key":"9d7f365ba966","markDefs":[],"children":[{"marks":[],"text":"","_key":"85bc489e03f40","_type":"span"}]},{"style":"normal","_key":"b5e231a22dbf","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Aggression that occurs in patients with psychiatric disorders may frequently fuel psychiatric presentation to either the emergency or inpatient setting. Clinicians tend to choose treatments based on the diagnosis. However, if aggression is a major issue, it may be reasonable to choose a treatment that has demonstrated efficacy to address aggression. The availability of agents that have demonstrated efficacy in aggression should be considered when choosing treatments for patients who present with aggression as a primary symptom.","_key":"afd045c64f0c0"}],"_type":"block"},{"_type":"block","style":"normal","_key":"4edb09e6a7cf","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"754427ff02c70"}]},{"style":"normal","_key":"6c473f05afcb","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Dr El-Mallakh ","_key":"90a97cfe5fe10"},{"_type":"span","marks":["em"],"text":"is a professor in the department of psychiatry and behavioral sciences and director of the Mood Disorders Research Program at the University of Louisville School of Medicine in Louisville, Kentucky. ","_key":"90a97cfe5fe11"},{"marks":["strong"],"text":"Dr Aydin ","_key":"90a97cfe5fe12","_type":"span"},{"_type":"span","marks":["em"],"text":"is a postdoctoral researcher at","_key":"90a97cfe5fe13"},{"_type":"span","marks":[],"text":" ","_key":"90a97cfe5fe14"},{"_type":"span","marks":["em"],"text":"the University of Louisville School of Medicine in Louisville, Kentucky.","_key":"90a97cfe5fe15"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"c87820cb47a50"}],"_type":"block","style":"normal","_key":"04a830889b15"},{"children":[{"_type":"span","marks":["strong"],"text":"References","_key":"3a0e0ca00ab70"}],"_type":"block","style":"normal","_key":"1af9e1ae593e","markDefs":[]},{"_type":"block","style":"normal","_key":"e72697b86550","markDefs":[{"blank":true,"_type":"link","href":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8783168/","_key":"ac68ff4a2c04"}],"children":[{"_key":"0f184534c3ba0","_type":"span","marks":[],"text":"1. Girasek H, Nagy VA, Fekete S, et al. "},{"_type":"span","marks":["ac68ff4a2c04"],"text":"Prevalence and correlates of aggressive behavior in psychiatric inpatient populations.","_key":"0f184534c3ba1"},{"_type":"span","marks":[],"text":" ","_key":"5a4f8003cff4"},{"text":"World J Psychiatry","_key":"0f184534c3ba2","_type":"span","marks":["em"]},{"text":". 2022;12(1):1-23.","_key":"0f184534c3ba3","_type":"span","marks":[]}]},{"markDefs":[{"href":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1508769/","_key":"0a44e22c5ea6","blank":true,"_type":"link"}],"children":[{"_key":"955010daff290","_type":"span","marks":[],"text":"2. Pescosolido BA, Monahan J, Link BG, et al. 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Additional studies have shown lumateperone's effectiveness as an adjunctive therapy for major depressive disorder and in treating bipolar depression with mixed features.","title":"Positive Phase 3 Results Evaluating Lumateperone for the Prevention of Relapse in Schizophrenia","articleType":"News","thumbnail":{"alt":"schizophrenia","caption":"Adin/AdobeStock","asset":{"_ref":"image-aa32b9c9311ae9016ca84e15914daf1d3645a569-6272x3584-jpg","_type":"reference"},"_type":"mainImage"},"url":"positive-phase-3-results-evaluating-lumateperone-for-the-prevention-of-relapse-in-schizophrenia","_createdAt":"2024-11-06T17:13:24Z","_rev":"VWkKPc20DpnhdCi8xbD2u0","audioUrl":"https://s3.us-east-1.amazonaws.com/ai-generated-audios/www.psychiatrictimes.com/805355a7-27a5-41fb-91d6-06a7576fe648_1730913207062.94299cb8-888c-46d2-bd96-46a31f4d4a16.mp3","authorMapping":[{"firstName":"Leah","displayName":"Leah Kuntz","_rev":"AHAMphbTGS6uc0RcJHCpre","_id":"eae211d2-ac5b-40d6-9e4b-b25ee06057f2","_updatedAt":"2020-10-06T13:25:26Z","url":{"current":"leah-kuntz","_type":"slug"},"lastName":"Kuntz","_createdAt":"2020-10-06T13:25:26Z","_type":"author"}],"is_visible":true,"ExcludeFromPubMedXML":false,"gptTakeaways":"• Lumateperone 42 mg significantly delayed symptom relapse in schizophrenia, reducing relapse risk by 63% compared to placebo.\n\n• The study met both primary and secondary endpoints, demonstrating efficacy and improved treatment discontinuation rates.\n\n• Lumateperone was generally well tolerated, with headache being the most common adverse event.\n\n• Additional studies confirmed lumateperone's efficacy in major depressive disorder and bipolar depression with mixed features.","body":[{"_key":"f6f9d8e6e353","asset":{"_ref":"image-aa32b9c9311ae9016ca84e15914daf1d3645a569-6272x3584-jpg","_type":"reference"},"blank":true,"_type":"figure","alt":"schizophrenia","imgcaption":[{"_key":"a77123d23453","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Adin/AdobeStock","_key":"f1f3dbb18bb70"}],"_type":"block","style":"normal"}],"disableTextWrap":false,"disableLightBox":true,"alignment":"left","widthP":49},{"children":[{"_type":"span","marks":[],"text":"Intra-Cellular Therapies recently announced positive results from study 304 evaluating the efficacy and safety of lumateperone (Caplyta) 42 mg for the prevention of relapse in adult patients with schizophrenia.","_key":"7c636c027da50"},{"_type":"span","marks":["superscript"],"text":"1","_key":"e22f990b71ce"}],"_type":"block","style":"normal","_key":"53971932b6cd","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"906eb46f39590"}],"_type":"block","style":"normal","_key":"e89d35eaa7f3"},{"_type":"block","style":"normal","_key":"3b86b0da828b","markDefs":[],"children":[{"text":"“Schizophrenia is a chronic, serious mental illness characterized by the occurrence of acute psychotic episodes that cumulatively worsen disease prognosis. The control of symptoms and the prevention of relapses is critical to improving long-term patient outcomes. We are very pleased that the results from study 304, a randomized withdrawal trial, demonstrated efficacy along with favorable safety and tolerability which support the benefit of continued long-term treatment with lumateperone,” said Suresh Durgam, MD, executive vice president and chief medical officer of Intra-Cellular Therapies.","_key":"5fcb4902fb1f0","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"1","_key":"4c9eee1381fe"}]},{"_type":"block","style":"normal","_key":"746b6822f2b2","markDefs":[],"children":[{"_key":"496ff8a982f50","_type":"span","marks":[],"text":""}]},{"_type":"block","style":"normal","_key":"703dcdfb0ebf","markDefs":[],"children":[{"marks":[],"text":"Study 304 was a multicenter, multi-national, randomized, double-blind, placebo-controlled, parallel group study evaluating lumateperone for the prevention of symptomatic relapse in adults with schizophrenia. During this 47-week study, there was an 18-week open-label phase where patients with schizophrenia were treated with lumateperone 42 mg per day, and those who met the stabilization criteria during that period progressed to the double-blind treatment phase. Patients were randomized to continue lumateperone 42 mg (N=114) or switched to placebo (N=114) for up to 26 weeks or until relapse occurred.","_key":"f2115b63698f0","_type":"span"}]},{"_key":"1f8ce01388e5","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"8c9224a170700"}],"_type":"block","style":"normal"},{"style":"normal","_key":"98311d35c8d4","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Lumateperone met the primary endpoint, which was time to first symptom relapse; time to relapse during the double-blind treatment phase was significantly longer in participants on lumateperone compared with those receiving placebo (","_key":"0b5694de7ff30"},{"_type":"span","marks":["em"],"text":"P","_key":"0b5694de7ff31"},{"_type":"span","marks":[],"text":"=0.0002). There were 18 relapses (16.4%) in the lumateperone group vs 44 relapses (38.6%) in the placebo group. Treatment with lumateperone was associated with a 63% reduction in risk of relapse vs placebo (hazard ratio [95% CI] = 0.37, [0.22, 0.65]).","_key":"0b5694de7ff32"}],"_type":"block"},{"_key":"d17fde16329d","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"01b2be22e5770"}],"_type":"block","style":"normal"},{"style":"normal","_key":"e6813adbed86","markDefs":[],"children":[{"text":"The secondary endpoint was time to all cause discontinuation during the double-blind phase, and it was also met (","_key":"6baf39b533ff0","_type":"span","marks":[]},{"text":"P","_key":"6baf39b533ff1","_type":"span","marks":["em"]},{"_type":"span","marks":[],"text":"=0.0007), showing better treatment discontinuation rates during the double-blind phase.","_key":"6baf39b533ff2"}],"_type":"block"},{"style":"normal","_key":"ed1d31e0028d","markDefs":[],"children":[{"_key":"f10dbdc2735c0","_type":"span","marks":[],"text":""}],"_type":"block"},{"_key":"d14d48490b74","markDefs":[],"children":[{"_type":"span","marks":[],"text":"As to safety profile, lumateperone was generally safe and well tolerated in this study. In the double-blind phase, the most commonly reported adverse event that was observed at a rate greater than or equal to 5% and twice the rate of placebo was headache.","_key":"2eed732671790"}],"_type":"block","style":"normal"},{"style":"normal","_key":"13a78455c432","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"9adbb34ebe9b0"}],"_type":"block"},{"children":[{"_type":"span","marks":[],"text":"Earlier this year, Intra-Cellular Therapies’ study 502 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder saw positive results.","_key":"ccba591707d20"},{"_type":"span","marks":["superscript"],"text":"2","_key":"cd1865040a6e"},{"_key":"c5edc3703329","_type":"span","marks":[],"text":" Lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints, robustly improved depressive symptoms as reported by patients as measured by the Quick Inventory of Depressive Symptomatology Self Report ("},{"_type":"span","marks":["em"],"text":"P","_key":"ccba591707d21"},{"text":"\u003c0.0001), a 16-item patient-rated scale of symptom severity in depression that assesses 9 key symptoms. 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