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Bender, PharmD, MA</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="SAINT iTBS Protocol Shows Promise for Bipolar I Depression" 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="SAINT iTBS Protocol Shows Promise for Bipolar I Depression" aria-label="pinterest" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg viewBox="0 0 64 64" width="32" height="32"><circle cx="32" cy="32" r="31" fill="#cb2128"></circle><path d="M32,16c-8.8,0-16,7.2-16,16c0,6.6,3.9,12.2,9.6,14.7c0-1.1,0-2.5,0.3-3.7 c0.3-1.3,2.1-8.7,2.1-8.7s-0.5-1-0.5-2.5c0-2.4,1.4-4.1,3.1-4.1c1.5,0,2.2,1.1,2.2,2.4c0,1.5-0.9,3.7-1.4,5.7 c-0.4,1.7,0.9,3.1,2.5,3.1c3,0,5.1-3.9,5.1-8.5c0-3.5-2.4-6.1-6.7-6.1c-4.9,0-7.9,3.6-7.9,7.7c0,1.4,0.4,2.4,1.1,3.1 c0.3,0.3,0.3,0.5,0.2,0.9c-0.1,0.3-0.3,1-0.3,1.3c-0.1,0.4-0.4,0.6-0.8,0.4c-2.2-0.9-3.3-3.4-3.3-6.1c0-4.5,3.8-10,11.4-10 c6.1,0,10.1,4.4,10.1,9.2c0,6.3-3.5,11-8.6,11c-1.7,0-3.4-0.9-3.9-2c0,0-0.9,3.7-1.1,4.4c-0.3,1.2-1,2.5-1.6,3.4 c1.4,0.4,3,0.7,4.5,0.7c8.8,0,16-7.2,16-16C48,23.2,40.8,16,32,16z" fill="white"></path></svg></button><button aria-label="email" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg viewBox="0 0 64 64" width="32" height="32"><circle cx="32" cy="32" r="31" fill="#7f7f7f"></circle><path d="M17,22v20h30V22H17z M41.1,25L32,32.1L22.9,25H41.1z M20,39V26.6l12,9.3l12-9.3V39H20z" fill="white"></path></svg></button><a class="print-wrap flex justify-center items-center cursor-pointer"><svg id="print" xmlns="http://www.w3.org/2000/svg" width="24" height="24" fill="currentColor" class="print bi bi-printer" viewBox="0 0 16 16"> <path d="M2.5 8a.5.5 0 1 0 0-1 .5.5 0 0 0 0 1z"></path> <path d="M5 1a2 2 0 0 0-2 2v2H2a2 2 0 0 0-2 2v3a2 2 0 0 0 2 2h1v1a2 2 0 0 0 2 2h6a2 2 0 0 0 2-2v-1h1a2 2 0 0 0 2-2V7a2 2 0 0 0-2-2h-1V3a2 2 0 0 0-2-2H5zM4 3a1 1 0 0 1 1-1h6a1 1 0 0 1 1 1v2H4V3zm1 5a2 2 0 0 0-2 2v1H2a1 1 0 0 1-1-1V7a1 1 0 0 1 1-1h12a1 1 0 0 1 1 1v3a1 1 0 0 1-1 1h-1v-1a2 2 0 0 0-2-2H5zm7 2v3a1 1 0 0 1-1 1H5a1 1 0 0 1-1-1v-3a1 1 0 0 1 1-1h6a1 1 0 0 1 1 1z"></path></svg></a></div><style> .print-wrap { width: 32px; height: 32px; background: #7F7F7F; border-radius: 100%; } .print { background: #7F7F7F; color: white; padding: 2px; border-radius: 100%; } </style></div><style> video::cue { display: inline; background-color: #b8dcf6; padding: 2px 2px; } audio { height: 40px; } .rhap_container { width: 300px !important; border-radius: 100px !important; height: 40px !important; box-shadow: 0px 0px 2px 2px rgba(0,0,0,0.1); } .rhap_progress-section { width: 150px; margin-left: 35px; } .rhap_controls-section { position: relative; bottom: .75rem; } .rhap_time { font-size: 12px; color: rgb(0,55,103); } .rhap_progress-bar { color: rgb(0,55,103) !important; } .rhap_progress-filled { background-color: rgb(0,55,103) !important; } .rhap_progress-indicator { height: 15px; width: 5px; top: -5px; margin-left: 1px; background-color: rgb(0,55,103) !important; } .rhap_repeat-button { display: none; } .rhap_volume-bar, rhap_volume-button, .rhap_volume-indicator { background: rgb(0,55,103) !important; } .rhap_volume-bar { height: 2px; width: 35px; position: relative; left: 22px; bottom: 21px; } .rhap_volume-button { // width: 5px; // height: 5px; flex: 0 0 26px; position: relative; left: 22px; bottom: 21px; } .rhap_volume-button svg { height: 18px; width: 18px; } .rhap_volume-indicator { height: 8px; width: 8px; top: -2.75px } .rhap_button-clear { color: rgb(0,55,103) !important; } .rhap_play-pause-button { color: rgb(0,55,103) !important; font-size: 30px !important; width: 30px !important; height: 30px !important; position: relative; right: 90px; bottom: 22px; } .rhap_main-controls button { color: rgb(0,55,103) !important; } audio::-webkit-media-controls-play-button, video::-webkit-media-controls-play-button { -webkit-appearance: media-play-button; color: #b8dcf6; } audio::-webkit-media-controls-panel { background-color: white !important; color: #000; } audio::-webkit-media-controls-current-time-display, audio::-webkit-media-controls-time-remaining-display { font-size: 12px; } </style></div></div></div><div class=" lg:w-full flex flex-col lg:flex-row lg:items-center lg:justify-end"></div><div class="w-full flex flex-col px-4 py-4 border-t border-b border-solid border-gray-400 my-4 "><h3 class="text-primary text-xl font-semibold">Key Takeaways</h3><ul class="list-disc px-8"><li class="py-2 "> SAINT protocol rapidly reduced depressive symptoms in bipolar I disorder, achieving 60% remission within a month post-treatment without adverse cognitive or manic effects. </li><li class="py-2 "> The study involved 10 participants with moderate to severe depression unresponsive to antidepressants, using fMRI-targeted iTBS over five days. </li><li class="py-2 hidden"> Further research is planned to validate these findings with a larger, double-blinded, sham-controlled trial.</li></ul><span class="text-xs font-bold text-primary underline cursor-pointer mt-2 ml-4">SHOW MORE</span></div><p class="py-2 mb-2 text-sm italic text-gray-600">A refined rTMS protocol, the Stanford Accelerated Intelligent Neuromodulation Therapy for major depressive disorder, shows promise in bipolar disorder.</p><div class="py-2"><div class="blockText_blockContent__TbCXh"><div class=""><div style="width:49%;float:left;max-width:525px;margin:0 1.5rem 1.5rem 0;clear:both;cursor:" class=" figure"><div class="flex-none relative text-center"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%272000%27%20height=%272000%27/%3e"/></span><img alt="bipolar" title="bipolar" 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="bipolar" title="bipolar" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2F738ebb291ae9b226a64c2958546f0756b62b47fc-2000x2000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=2048&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2F738ebb291ae9b226a64c2958546f0756b62b47fc-2000x2000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2F738ebb291ae9b226a64c2958546f0756b62b47fc-2000x2000.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain" loading="lazy"/></noscript></span></div><div id="image-caption" class="text-gray-500 italic"><div class="blockText_blockContent__TbCXh"><p class="pb-2">Dariia/AdobeStock</p></div></div><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/psychtimes/738ebb291ae9b226a64c2958546f0756b62b47fc-2000x2000.jpg?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2">The Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT),<sup class="text-inherit">1</sup> a refined, rapidly acting protocol of repetitive transcranial magnetic stimulation (rTMS) approved for treatment-resistant <a target="_blank" href="https://www.psychiatrictimes.com/topics/major-depressive-disorder">major depressive disorder</a>,<sup class="text-inherit">2</sup> has now demonstrated promise for reducing depressive symptoms of bipolar I disorder in an open-label, feasibility and safety trial.<sup class="text-inherit">3</sup></p><p class="pb-2"></p><p class="pb-2">“We found that SAINT rapidly reduced depressive symptoms with 60% of participants meeting remission criteria during the 1-month period following treatment,” reported lead author Kevin Li, MD, Department of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine Baltimore, MD, and colleagues.</p><p class="pb-2"></p><p class="pb-2">“Moreover, the treatment was not associated with adverse cognitive or other side effects, including the emergence of manic symptoms,” Li and colleagues added.</p><p class="pb-2"></p><p class="pb-2">Brandon Bentzley, MD, PhD, cofounder and chief scientific officer, Burlingame, CA, the licensee of the SAINT protocol, remarked on the importance of investigating possible application for patients with <a target="_blank" href="https://www.psychiatrictimes.com/topics/major-depressive-disorder">bipolar disorder</a> in discussing the trial with <em>Psychiatric Times</em>.</p><p class="pb-2"></p><p class="pb-2">“People with bipolar 1 disorder spend much more time in depressive episodes than manic episodes. Depression causes severe disability to those who suffer from bipolar I disorder, and many do not benefit or cannot tolerate current treatments for their bipolar I depression,” Bentzley said.</p><p class="pb-2"></p><p class="pb-2">The investigators identified 14 patients with bipolar I disorder experiencing moderate to severe depression unrelieved by antidepressant treatment at the 2 study sites at Johns Hopkins University and the University of Texas at Austin. Four of the candidates were excluded due to a current mixed episode, severe ongoing cannabis abuse, an insufficient prior antidepressant trial, or a manic episode with the prior 6 months.</p><p class="pb-2"></p><p class="pb-2">The 10 trial participants, 6 of them female, were White and ranged between 21 to 63 years of age. At screening, each of the participants was experiencing a major depressive episode (MADRS score greater than 20) while on an antidepressant and had been on an antimanic agent at adequate dose and without dose change for at least 6 weeks. Additional requirements of participation were a minimum of 6 months since the last manic or hypomanic episode and 3 months since electroconvulsive therapy.</p><p class="pb-2"></p><p class="pb-2">In the SAINT protocol, participants undergo structural and resting-state functional magnetic resonance imaging (fMRI) to identify the target above the scalp to focus intermittent theta burst stimulation (iTBS) above the dorsolateral prefrontal cortex (DLPFC). Participants underwent 10 sessions of the targeted iTBS daily, with 50-minute intervals, for up to 5 days.</p><p class="pb-2"></p><p class="pb-2">A battery of measures was applied at baseline, immediately after completion of the iTBS series and at 1 month follow-up. The study primary outcome was change in MADRS score from baseline. Secondary outcomes included rates of clinical response (MADRS score reduction of greater than or equal to 50%) and remission (MADRS score of 10 or less). The possible emergence of mania/hypomania was evaluated with the Young Mania Rating Scale at the beginning and end of each treatment day.</p><p class="pb-2"></p><p class="pb-2">Li and colleagues reported a mean reduction of 16.9 in MADRS scores, with a 50% response rate and 40% remission rate immediately after treatment. Remission criteria were met by 60% of participants within the 1-month follow-up period. No serious adverse events, manic episodes, or cognitive adverse effects were reported.</p><p class="pb-2"></p><p class="pb-2">"We are very pleased by the outcomes of this pilot trial, especially given that the participants all had already tried first-line medication treatments for their depression, without improvement in their conditions, even after months-to-years of treatment," Bentzley commented.</p><p class="pb-2"></p><p class="pb-2"><strong>SAINT iTBS Refines rTMS for Depression</strong></p><p class="pb-2">In 2022, 14 years after the 2008 US Food and Drug Administration (FDA) approval of an rTMS system for treatment-resistant major depressive disorder,<sup class="text-inherit">4</sup> the FDA approved the SAINT Neuromodulation System (Magnus Medical).<sup class="text-inherit">2</sup> The product name is derived from the SAINT acronym for the protocol developed by Nolan Williams, MD, and colleagues at Stanford University.</p><p class="pb-2"></p><p class="pb-2">Williams, a coauthor of the present study, and colleagues had found that while rTMS magnetic pulses could not directly reach the subgenual anterior cingulate cortex associated with affect, activity in that region could be modulated through stimulation pulses to the DLPFC. Identifying a target point above the scalp with fMRI to maximize effect on the DLPFC was necessary as it varies between individuals.</p><p class="pb-2"></p><p class="pb-2">The SAINT protocol of iTBS administers the same amount of brain stimulation as the weeks-long FDA-approved rTMS regimen but does so within 5 days. Sessions last for 3 minutes compared with 37 minutes in conventional TMS. Ten sessions of iTBS are administered per day for up to 5 days, with 50 minutes separating the sessions.</p><p class="pb-2"></p><p class="pb-2">The administration schedule, Williams recounted in an earlier interview,<sup class="text-inherit">5</sup> was designed to "build upon one another to amplify the antidepressant effect."</p><p class="pb-2"></p><p class="pb-2">In that interview, Williams acknowledged that the use of the fMRI scan to pinpoint the target for stimulation adds to the cost of the procedure. He indicated, however, that it also increases its accuracy and effectiveness, which could be lifesaving in patients with refractory major depression.</p><p class="pb-2"></p><p class="pb-2">The current study is the first to use SAINT in patients with bipolar I depression since its development at Stanford. Li and colleagues consider the findings promising and indicate that further investigation is warranted; suggesting that it be double-blinded, sham-controlled, and conducted with a larger sample size and longer follow-up.</p><p class="pb-2"></p><p class="pb-2">Bentzley confirmed intention to further investigate the SAINT protocol for bipolar depression. “The next step will be a larger clinical trial, and we are currently investigating the best path to undertake this next step,” he said.</p><p class="pb-2"></p><p class="pb-2"><strong>Dr Bender</strong><em> reports on medical innovations and advances in practice and edits presentations for news and professional education publications. He previously taught and mentored pharmacy and medical students, and he provided and managed pharmacy care and drug information services.</em></p><p class="pb-2"></p><p class="pb-2"><strong>References</strong></p><p class="pb-2">1. Cole EJ, Stimpson RH, Bentzley BS, et al. <a rel="nofollow noreferrer noopener" target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/32252538/">Stanford accelerated intelligent neuromodulatoin therapy for treatment-resistant depression.</a> <em>Am J Psychiatry. </em>2020;177(8):716-726.</p><p class="pb-2">2. Magnus Medical receives FDA clearance for the SAINT neuromodulation system for non-invasive, individualized and precise treatment of severe depression. Magnus Medical. News release. September 6, 2022. Accessed November 1, 2024. <a rel="nofollow noreferrer noopener" target="_blank" href="https://www.magnusmed.com/press-releases/magnus-medical-receives-fda-clearance-for-the-saint-neuromodulation-system/">https://www.magnusmed.com/press-releases/magnus-medical-receives-fda-clearance-for-the-saint-neuromodulation-system/</a></p><p class="pb-2">3. Li K, Bichlmeier A, DuPont C, et al. <a rel="nofollow noreferrer noopener" target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/39154984/">Fast depressive symptoms improvement in bipolar 1 disorder after Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT): a two-site feasibility and safety open-label trial.</a> <em>J Affect Disord. </em>2024;365:359-363.</p><p class="pb-2">4. Horvath JC, Mathews J, Demitrack MA, Pascual-Leone A. <a rel="nofollow noreferrer noopener" target="_blank" href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3159591/">The NeuroStar TMS device: conducting the FDA approved protocol for treatment of depression.</a> <em>J Vis Exp. </em>2010;45:2345.</p><p class="pb-2">5. Tarr P. FDA clears SAINT rapid-acting brain stimulation approach for those suffering from resistant major depression. Brain & Behavior Research Foundation. September 15, 2022. Accessed November 1, 2024. <a rel="nofollow noreferrer noopener" target="_blank" href="https://bbrfoundation.org/content/fda-clears-saint-rapid-acting-brain-stimulation-approach-those-suffering-resistant-major">https://bbrfoundation.org/content/fda-clears-saint-rapid-acting-brain-stimulation-approach-those-suffering-resistant-major</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 space-y-3 flex-none select-none no-underline" 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class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 12th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/newly-fda-cleared-tms-for-major-depressive-disorder-obsessive-compulsive-disorder-and-anxious-depression?utm_source=www.psychiatrictimes.com&utm_medium=relatedContent">Newly FDA-Cleared TMS for Major Depressive Disorder, Obsessive-Compulsive Disorder, and Anxious Depression</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/newly-fda-cleared-tms-for-major-depressive-disorder-obsessive-compulsive-disorder-and-anxious-depression?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":"SAINT iTBS Protocol Shows Promise for Bipolar I Depression","datePublished":"2024-11-04T15:00:00.000Z","dateModified":"2024-11-04T20:46:03Z","inLanguage":"en-US","image":"https://cdn.sanity.io/images/0vv8moc6/psychtimes/738ebb291ae9b226a64c2958546f0756b62b47fc-2000x2000.jpg?fit=crop&auto=format","mainEntityOfPage":{"@type":"WebPage","@id":"https://www.psychiatrictimes.com/view/saint-itbs-protocol-shows-promise-for-bipolar-i-depression"},"publisher":{"@type":"Organization","name":"Psychiatric Times","logo":{"@type":"ImageObject","url":"https://www.psychiatrictimes.com/PsychiatricTimesLogo.png"}},"articleBody":"\n\nThe Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT),1 a refined, rapidly acting protocol of repetitive transcranial magnetic stimulation (rTMS) approved for treatment-resistant major depressive disorder,2 has now demonstrated promise for reducing depressive symptoms of bipolar I disorder in an open-label, feasibility and safety trial.3\n\n\n\n“We found that SAINT rapidly reduced depressive symptoms with 60% of participants meeting remission criteria during the 1-month period following treatment,” reported lead author Kevin Li, MD, Department of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine Baltimore, MD, and colleagues.\n\n\n\n“Moreover, the treatment was not associated with adverse cognitive or other side effects, including the emergence of manic symptoms,” Li and colleagues added.\n\n\n\nBrandon Bentzley, MD, PhD, cofounder and chief scientific officer, Burlingame, CA, the licensee of the SAINT protocol, remarked on the importance of investigating possible application for patients with bipolar disorder in discussing the trial with Psychiatric Times.\n\n\n\n“People with bipolar 1 disorder spend much more time in depressive episodes than manic episodes. Depression causes severe disability to those who suffer from bipolar I disorder, and many do not benefit or cannot tolerate current treatments for their bipolar I depression,” Bentzley said.\n\n\n\nThe investigators identified 14 patients with bipolar I disorder experiencing moderate to severe depression unrelieved by antidepressant treatment at the 2 study sites at Johns Hopkins University and the University of Texas at Austin. Four of the candidates were excluded due to a current mixed episode, severe ongoing cannabis abuse, an insufficient prior antidepressant trial, or a manic episode with the prior 6 months.\n\n\n\nThe 10 trial participants, 6 of them female, were White and ranged between 21 to 63 years of age. At screening, each of the participants was experiencing a major depressive episode (MADRS score greater than 20) while on an antidepressant and had been on an antimanic agent at adequate dose and without dose change for at least 6 weeks. Additional requirements of participation were a minimum of 6 months since the last manic or hypomanic episode and 3 months since electroconvulsive therapy.\n\n\n\nIn the SAINT protocol, participants undergo structural and resting-state functional magnetic resonance imaging (fMRI) to identify the target above the scalp to focus intermittent theta burst stimulation (iTBS) above the dorsolateral prefrontal cortex (DLPFC). Participants underwent 10 sessions of the targeted iTBS daily, with 50-minute intervals, for up to 5 days.\n\n\n\nA battery of measures was applied at baseline, immediately after completion of the iTBS series and at 1 month follow-up. The study primary outcome was change in MADRS score from baseline. Secondary outcomes included rates of clinical response (MADRS score reduction of greater than or equal to 50%) and remission (MADRS score of 10 or less). The possible emergence of mania/hypomania was evaluated with the Young Mania Rating Scale at the beginning and end of each treatment day.\n\n\n\nLi and colleagues reported a mean reduction of 16.9 in MADRS scores, with a 50% response rate and 40% remission rate immediately after treatment. Remission criteria were met by 60% of participants within the 1-month follow-up period. No serious adverse events, manic episodes, or cognitive adverse effects were reported.\n\n\n\n\"We are very pleased by the outcomes of this pilot trial, especially given that the participants all had already tried first-line medication treatments for their depression, without improvement in their conditions, even after months-to-years of treatment,\" Bentzley commented.\n\n\n\nSAINT iTBS Refines rTMS for Depression\n\nIn 2022, 14 years after the 2008 US Food and Drug Administration (FDA) approval of an rTMS system for treatment-resistant major depressive disorder,4 the FDA approved the SAINT Neuromodulation System (Magnus Medical).2 The product name is derived from the SAINT acronym for the protocol developed by Nolan Williams, MD, and colleagues at Stanford University.\n\n\n\nWilliams, a coauthor of the present study, and colleagues had found that while rTMS magnetic pulses could not directly reach the subgenual anterior cingulate cortex associated with affect, activity in that region could be modulated through stimulation pulses to the DLPFC. Identifying a target point above the scalp with fMRI to maximize effect on the DLPFC was necessary as it varies between individuals.\n\n\n\nThe SAINT protocol of iTBS administers the same amount of brain stimulation as the weeks-long FDA-approved rTMS regimen but does so within 5 days. Sessions last for 3 minutes compared with 37 minutes in conventional TMS. Ten sessions of iTBS are administered per day for up to 5 days, with 50 minutes separating the sessions.\n\n\n\nThe administration schedule, Williams recounted in an earlier interview,5 was designed to \"build upon one another to amplify the antidepressant effect.\"\n\n\n\nIn that interview, Williams acknowledged that the use of the fMRI scan to pinpoint the target for stimulation adds to the cost of the procedure. He indicated, however, that it also increases its accuracy and effectiveness, which could be lifesaving in patients with refractory major depression.\n\n\n\nThe current study is the first to use SAINT in patients with bipolar I depression since its development at Stanford. Li and colleagues consider the findings promising and indicate that further investigation is warranted; suggesting that it be double-blinded, sham-controlled, and conducted with a larger sample size and longer follow-up.\n\n\n\nBentzley confirmed intention to further investigate the SAINT protocol for bipolar depression. “The next step will be a larger clinical trial, and we are currently investigating the best path to undertake this next step,” he said.\n\n\n\nDr Bender reports on medical innovations and advances in practice and edits presentations for news and professional education publications. He previously taught and mentored pharmacy and medical students, and he provided and managed pharmacy care and drug information services.\n\n\n\nReferences\n\n1. Cole EJ, Stimpson RH, Bentzley BS, et al. Stanford accelerated intelligent neuromodulatoin therapy for treatment-resistant depression. Am J Psychiatry. 2020;177(8):716-726.\n\n2. Magnus Medical receives FDA clearance for the SAINT neuromodulation system for non-invasive, individualized and precise treatment of severe depression. Magnus Medical. News release. September 6, 2022. Accessed November 1, 2024. https://www.magnusmed.com/press-releases/magnus-medical-receives-fda-clearance-for-the-saint-neuromodulation-system/\n\n3. Li K, Bichlmeier A, DuPont C, et al. Fast depressive symptoms improvement in bipolar 1 disorder after Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT): a two-site feasibility and safety open-label trial. J Affect Disord. 2024;365:359-363.\n\n4. Horvath JC, Mathews J, Demitrack MA, Pascual-Leone A. The NeuroStar TMS device: conducting the FDA approved protocol for treatment of depression. J Vis Exp. 2010;45:2345.\n\n5. Tarr P. FDA clears SAINT rapid-acting brain stimulation approach for those suffering from resistant major depression. Brain & Behavior Research Foundation. September 15, 2022. Accessed November 1, 2024. https://bbrfoundation.org/content/fda-clears-saint-rapid-acting-brain-stimulation-approach-those-suffering-resistant-major","description":"A refined rTMS protocol, the Stanford Accelerated Intelligent Neuromodulation Therapy for major depressive disorder, shows promise in bipolar disorder.","author":[{"@type":"Person","name":"Kenneth J. Bender, PharmD, MA"}]}</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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Four of the candidates were excluded due to a current mixed episode, severe ongoing cannabis abuse, an insufficient prior antidepressant trial, or a manic episode with the prior 6 months.","_key":"fea170af90180","_type":"span"}],"_type":"block","style":"normal"},{"style":"normal","_key":"ec22241bad1f","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"7d611cf9efa70"}],"_type":"block"},{"_key":"dbce69094cc6","markDefs":[],"children":[{"_key":"14ff7330f7d00","_type":"span","marks":[],"text":"The 10 trial participants, 6 of them female, were White and ranged between 21 to 63 years of age. At screening, each of the participants was experiencing a major depressive episode (MADRS score greater than 20) while on an antidepressant and had been on an antimanic agent at adequate dose and without dose change for at least 6 weeks. Additional requirements of participation were a minimum of 6 months since the last manic or hypomanic episode and 3 months since electroconvulsive therapy."}],"upload_doc":null,"uploadAudio":null,"medias":null,"_type":"block","style":"normal"},{"_key":"47d50f659473","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"f6894f1b557b0"}],"_type":"block","style":"normal"},{"style":"normal","_key":"7a3dc5f70355","markDefs":[],"children":[{"marks":[],"text":"In the SAINT protocol, participants undergo structural and resting-state functional magnetic resonance imaging (fMRI) to identify the target above the scalp to focus intermittent theta burst stimulation (iTBS) above the dorsolateral prefrontal cortex (DLPFC). Participants underwent 10 sessions of the targeted iTBS daily, with 50-minute intervals, for up to 5 days.","_key":"a27c971e3a350","_type":"span"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"e4e0d3bfe4930"}],"_type":"block","style":"normal","_key":"b513c0b7de42","upload_doc":null,"uploadAudio":null,"medias":null},{"medias":null,"_key":"eaf940ac9f96","markDefs":[],"children":[{"marks":[],"text":"A battery of measures was applied at baseline, immediately after completion of the iTBS series and at 1 month follow-up. The study primary outcome was change in MADRS score from baseline. Secondary outcomes included rates of clinical response (MADRS score reduction of greater than or equal to 50%) and remission (MADRS score of 10 or less). The possible emergence of mania/hypomania was evaluated with the Young Mania Rating Scale at the beginning and end of each treatment day.","_key":"d89225c875130","_type":"span"}],"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null},{"_type":"block","style":"normal","_key":"5d4467a1a3a7","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"marks":[],"text":"","_key":"5288e5c5abd20","_type":"span"}]},{"uploadAudio":null,"medias":null,"_type":"block","style":"normal","_key":"94594cd5be6d","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Li and colleagues reported a mean reduction of 16.9 in MADRS scores, with a 50% response rate and 40% remission rate immediately after treatment. Remission criteria were met by 60% of participants within the 1-month follow-up period. No serious adverse events, manic episodes, or cognitive adverse effects were reported.","_key":"6370bd6c19c80"}],"upload_doc":null},{"markDefs":[],"children":[{"marks":[],"text":"","_key":"e1a471b30a1d0","_type":"span"}],"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"563ce585f72a"},{"style":"normal","_key":"19f8ac8a1a32","markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"marks":[],"text":"\"We are very pleased by the outcomes of this pilot trial, especially given that the participants all had already tried first-line medication treatments for their depression, without improvement in their conditions, even after months-to-years of treatment,\" Bentzley commented.","_key":"cf3ab6575cfe0","_type":"span"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"de3b25279b090"}],"_type":"block","style":"normal","_key":"ceea7b8459bb","upload_doc":null,"uploadAudio":null,"medias":null},{"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"2095220c4ac3","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"SAINT iTBS Refines rTMS for Depression","_key":"efb7e41e3dd50"}]},{"_key":"638d81494f91","markDefs":[],"children":[{"text":"In 2022, 14 years after the 2008 US Food and Drug Administration (FDA) approval of an rTMS system for treatment-resistant major depressive disorder,","_key":"5a9f21d71b150","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"4","_key":"819ec1e2bb07"},{"_type":"span","marks":[],"text":" the FDA approved the SAINT Neuromodulation System (Magnus Medical).","_key":"1e07ae634be5"},{"_type":"span","marks":["superscript"],"text":"2","_key":"2186d480fd57"},{"_type":"span","marks":[],"text":" The product name is derived from the SAINT acronym for the protocol developed by Nolan Williams, MD, and colleagues at Stanford University.","_key":"89eb6bf8e8fa"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal"},{"children":[{"_type":"span","marks":[],"text":"","_key":"1bab0497d63c0"}],"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"9c02bcdc3419","markDefs":[]},{"upload_doc":null,"uploadAudio":null,"medias":null,"_type":"block","style":"normal","_key":"154d9eb5d0c0","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Williams, a coauthor of the present study, and colleagues had found that while rTMS magnetic pulses could not directly reach the subgenual anterior cingulate cortex associated with affect, activity in that region could be modulated through stimulation pulses to the DLPFC. Identifying a target point above the scalp with fMRI to maximize effect on the DLPFC was necessary as it varies between individuals.","_key":"51c6818fb5070"}]},{"uploadAudio":null,"medias":null,"_type":"block","style":"normal","_key":"d11db1097e91","markDefs":[],"children":[{"marks":[],"text":"","_key":"90457e0905720","_type":"span"}],"upload_doc":null},{"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"347462290e06","markDefs":[],"children":[{"_type":"span","marks":[],"text":"The SAINT protocol of iTBS administers the same amount of brain stimulation as the weeks-long FDA-approved rTMS regimen but does so within 5 days. Sessions last for 3 minutes compared with 37 minutes in conventional TMS. Ten sessions of iTBS are administered per day for up to 5 days, with 50 minutes separating the sessions.","_key":"a77e64645cf60"}]},{"medias":null,"_type":"block","style":"normal","_key":"53cefb03e633","markDefs":[],"children":[{"text":"","_key":"ab02901cb39a0","_type":"span","marks":[]}],"upload_doc":null,"uploadAudio":null},{"style":"normal","_key":"3587ca8d7bcf","markDefs":[],"children":[{"_type":"span","marks":[],"text":"The administration schedule, Williams recounted in an earlier interview,","_key":"0ec39a5ff88a0"},{"marks":["superscript"],"text":"5","_key":"c19c1914872d","_type":"span"},{"_type":"span","marks":[],"text":" was designed to \"build upon one another to amplify the antidepressant effect.\"","_key":"24e50c570876"}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null},{"uploadAudio":null,"medias":null,"style":"normal","_key":"b858937a1038","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"9c65936728b10"}],"_type":"block","upload_doc":null},{"children":[{"text":"In that interview, Williams acknowledged that the use of the fMRI scan to pinpoint the target for stimulation adds to the cost of the procedure. He indicated, however, that it also increases its accuracy and effectiveness, which could be lifesaving in patients with refractory major depression.","_key":"6d709af2872f0","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"e8e5411d5382","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[]},{"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":[],"text":"","_key":"870bd14cd5c40"}],"_type":"block","style":"normal","_key":"7cb986fd9f3e","markDefs":[]},{"upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"The current study is the first to use SAINT in patients with bipolar I depression since its development at Stanford. Li and colleagues consider the findings promising and indicate that further investigation is warranted; suggesting that it be double-blinded, sham-controlled, and conducted with a larger sample size and longer follow-up.","_key":"41036e0520ad0"}],"_type":"block","style":"normal","_key":"94111b7fee8c"},{"_type":"block","style":"normal","_key":"650874735538","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"f75db0423c650"}]},{"children":[{"_type":"span","marks":[],"text":"Bentzley confirmed intention to further investigate the SAINT protocol for bipolar depression. “The next step will be a larger clinical trial, and we are currently investigating the best path to undertake this next step,” he said.","_key":"cf13e68d4de10"}],"_type":"block","style":"normal","_key":"9de0f46706ca","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[]},{"_key":"463f79160583","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"aedf0371cfd70"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"53b8ad5ec9c8","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"marks":["strong"],"text":"Dr Bender","_key":"02b213654e860","_type":"span"},{"_key":"02b213654e861","_type":"span","marks":["em"],"text":" reports on medical innovations and advances in practice and edits presentations for news and professional education publications. He previously taught and mentored pharmacy and medical students, and he provided and managed pharmacy care and drug information services."}]},{"markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":[],"text":"","_key":"7336938498380"}],"_type":"block","style":"normal","_key":"d2eb0f2356ef"},{"markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"text":"References","_key":"b368b3718f3f0","_type":"span","marks":["strong"]}],"_type":"block","style":"normal","_key":"1812d73863b3"},{"style":"normal","_key":"fdf60739d444","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[{"href":"https://pubmed.ncbi.nlm.nih.gov/32252538/","_key":"901377e8e724","nofollow":true,"blank":true,"_type":"link"}],"children":[{"_type":"span","marks":[],"text":"1. Cole EJ, Stimpson RH, Bentzley BS, et al. ","_key":"a10dac0930b00"},{"marks":["901377e8e724"],"text":"Stanford accelerated intelligent neuromodulatoin therapy for treatment-resistant depression.","_key":"d67f353f85cf","_type":"span"},{"_type":"span","marks":[],"text":" ","_key":"21f6bd6ab148"},{"_type":"span","marks":["em"],"text":"Am J Psychiatry. ","_key":"a10dac0930b01"},{"_type":"span","marks":[],"text":"2020;177(8):716-726.","_key":"a10dac0930b02"}],"_type":"block"},{"upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"900c93b9650c","markDefs":[{"blank":true,"_type":"link","href":"https://www.magnusmed.com/press-releases/magnus-medical-receives-fda-clearance-for-the-saint-neuromodulation-system/","_key":"f4f19a63d8b1"}],"children":[{"_type":"span","marks":[],"text":"2. Magnus Medical receives FDA clearance for the SAINT neuromodulation system for non-invasive, individualized and precise treatment of severe depression. Magnus Medical. News release. September 6, 2022. Accessed November 1, 2024. ","_key":"8ba7c544fd610"},{"_key":"8ba7c544fd611","_type":"span","marks":["f4f19a63d8b1"],"text":"https://www.magnusmed.com/press-releases/magnus-medical-receives-fda-clearance-for-the-saint-neuromodulation-system/"}],"_type":"block"},{"markDefs":[{"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/39154984/","_key":"fa440e2c6f62","blank":true}],"children":[{"_type":"span","marks":[],"text":"3. Li K, Bichlmeier A, DuPont C, et al. ","_key":"423f26e3b1f10"},{"_type":"span","marks":["fa440e2c6f62"],"text":"Fast depressive symptoms improvement in bipolar 1 disorder after Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT): a two-site feasibility and safety open-label trial.","_key":"423f26e3b1f11"},{"_type":"span","marks":[],"text":" ","_key":"423f26e3b1f12"},{"_type":"span","marks":["em"],"text":"J Affect Disord. 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","_key":"2414b4156fd33"},{"_type":"span","marks":[],"text":"2010;45:2345.","_key":"2414b4156fd34"}],"_type":"block","style":"normal"},{"uploadAudio":null,"medias":null,"_type":"block","style":"normal","_key":"a541a2e66f8a","markDefs":[{"_key":"6687a258e0ef","blank":true,"_type":"link","href":"https://bbrfoundation.org/content/fda-clears-saint-rapid-acting-brain-stimulation-approach-those-suffering-resistant-major"}],"children":[{"_type":"span","marks":[],"text":"5. Tarr P. FDA clears SAINT rapid-acting brain stimulation approach for those suffering from resistant major depression. Brain \u0026 Behavior Research Foundation. September 15, 2022. Accessed November 1, 2024. ","_key":"b79063759aaf0"},{"_type":"span","marks":["6687a258e0ef"],"text":"https://bbrfoundation.org/content/fda-clears-saint-rapid-acting-brain-stimulation-approach-those-suffering-resistant-major","_key":"b79063759aaf1"}],"upload_doc":null}],"articleType":"News","audioUrl":"https://s3.us-east-1.amazonaws.com/ai-generated-audios/www.psychiatrictimes.com/04c8944a-7248-42ac-bec2-a5f2e03459a4_1730475188746.06b62370-5f66-47f4-a8ea-7c67009ee827.mp3","published":"2024-11-04T15:00:00.000Z","documentGroupMapping":null,"filter":null,"gptSummary":"The Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) protocol, a rapid-acting repetitive transcranial magnetic stimulation (rTMS) method, shows promise in reducing depressive symptoms in bipolar I disorder. In a feasibility and safety trial, 60% of participants achieved remission within a month post-treatment, with no adverse cognitive or manic effects. The study involved 10 participants with moderate to severe depression unresponsive to antidepressants. The SAINT protocol uses fMRI to target the dorsolateral prefrontal cortex, delivering intermittent theta burst stimulation (iTBS) over five days. Further research is planned to validate these findings.","is_visible":true,"summary":"A refined rTMS protocol, the Stanford Accelerated Intelligent Neuromodulation Therapy for major depressive disorder, shows promise in bipolar disorder.","contentGroup":null,"contentCategory":{"_id":"8bdaa7fc-960a-4b57-b076-75fdce3741bb","name":"Articles"},"issueGroup":null,"factCheckAuthorMapping":null,"drugMentions":"{\"drug_mentions\": []}","pdfUrl":null,"thumbnail":{"hotspot":{"width":1,"x":0.5,"y":0.48739624023437506,"height":0.7238275146484376,"_type":"sanity.imageHotspot"},"_type":"mainImage","alt":"bipolar","caption":"Dariia/AdobeStock","asset":{"_ref":"image-738ebb291ae9b226a64c2958546f0756b62b47fc-2000x2000-jpg","_type":"reference"},"crop":{"_type":"sanity.imageCrop","right":0,"top":0.12548248291015623,"left":0,"bottom":0.15069000244140618}},"title":"SAINT iTBS Protocol Shows Promise for Bipolar I Depression","documentGroup":null,"ExcludeFromPubMedXML":false,"disableAds":false,"disableRelatedContent":false,"relatedArticles":[{"_type":"article","_updatedAt":"2024-11-21T16:16:56Z","taxonomyMapping":[{"_createdAt":"2020-03-26T06:11:21Z","identifier":"topics/bipolar","_rev":"77mZ7PORfofI3dBGfWalU3","name":"Bipolar Disorder","_updatedAt":"2023-03-31T19:08:00Z","cmeType":"per","_type":"taxonomy","pixelTrackingCode":null,"parent":{"isMainTopic":true,"_rev":"uvXJooXtzvjNOyx50HTt8m","name":"Topics","_createdAt":"2020-03-26T06:11:21Z","_type":"taxonomy","_id":"pst_taxonomy_53202_clinical","_updatedAt":"2023-03-31T19:15:59Z","identifier":"topics","parent":null},"perKeywordMapping":["Psychiatry","Neurology"],"_id":"pst_taxonomy_52_bipolardisorder"},{"perKeywordMapping":["Psychiatry","Neurology"],"_type":"taxonomy","pixelTrackingCode":null,"parent":{"_type":"taxonomy","_updatedAt":"2023-03-31T19:15:59Z","isMainTopic":true,"_createdAt":"2020-03-26T06:11:21Z","parent":null,"_rev":"uvXJooXtzvjNOyx50HTt8m","name":"Topics","_id":"pst_taxonomy_53202_clinical","identifier":"topics"},"_createdAt":"2020-03-26T06:11:21Z","_id":"pst_taxonomy_238_majordepressivedisorder","_updatedAt":"2024-02-29T16:00:14Z","identifier":"topics/major-depressive-disorder","cmeType":"per","_rev":"r4Rkjy04WvWq5fuPdnwLCI","name":"Major Depressive Disorder"},{"_updatedAt":"2024-02-21T20:35:27Z","identifier":"topics/ptsd","parent":{"_rev":"uvXJooXtzvjNOyx50HTt8m","_type":"taxonomy","_updatedAt":"2023-03-31T19:15:59Z","_createdAt":"2020-03-26T06:11:21Z","name":"Topics","_id":"pst_taxonomy_53202_clinical","parent":null,"identifier":"topics","isMainTopic":true},"_createdAt":"2020-03-26T06:11:21Z","_id":"pst_taxonomy_339_ptsd","_rev":"IakUcQKwj7kr3xQjaaTSXO","_type":"taxonomy","name":"PTSD","pixelTrackingCode":null},{"cmeType":"per","_createdAt":"2020-03-26T06:11:21Z","_updatedAt":"2024-02-28T20:45:13Z","parent":null,"pixelTrackingCode":null,"_id":"pst_taxonomy_641_depression","_type":"taxonomy","identifier":"topics/depression","_rev":"eEqAv6Sbdk37RM523WcvVR","perKeywordMapping":["Psychiatry","Neurology"],"name":"Depression"}],"title":"Coping with Diagnostic Uncertainty in Mixed States: Comparing Treatment Risks","thumbnail":{"_type":"mainImage","alt":"bipolar","caption":"matiasdelcarmine/AdobeStock","asset":{"_type":"reference","_ref":"image-7466224b747025da7c84318fef9678a0f34e2c49-3673x2960-jpg"}},"audioUrl":"https://s3.us-east-1.amazonaws.com/ai-generated-audios/www.psychiatrictimes.com/d6ba6b71-6f80-43bf-8395-883a2728f7bb_1731357840116.d3bbde24-0373-4319-9cbb-92d3c5c1db5e.mp3","documentGroup":null,"_createdAt":"2024-11-11T20:43:59Z","summary":"Let’s compare treatment risks when managing mixed states. ","_rev":"CD9JqQ0bQG227zfp2Rriu3","gptSummary":"Marissa's case highlights the diagnostic challenges in distinguishing between mixed depression and depression with PTSD. Her history suggests potential bipolarity, complicating treatment decisions. Antidepressants and lamotrigine are considered, with the latter offering better tolerability but less obvious applicability without hypomania history. The risks of antidepressant withdrawal and lamotrigine allergy, particularly Stevens-Johnson Syndrome, are compared. The article emphasizes the importance of patient education and weighing treatment risks, especially when diagnosis is uncertain. Clinicians should remain open to alternative explanations until effective outcomes are achieved.","published":"2024-11-26T16:00:00.000Z","url":"coping-with-diagnostic-uncertainty-in-mixed-states-comparing-treatment-risks","drugMentions":"{\"drug_mentions\": [\"Sertraline\", \"Lamotrigine\", \"Lurasidone\", \"lumateperone\", \"cariprazine\", \"iloperidone\", \"Quetiapine\", \"lithium\", \"venlafaxine\", \"desvenlafaxine\", \"escitalopram\", \"metformin\"]}","authorMapping":[{"_id":"pst_author_323669","_updatedAt":"2020-08-21T07:23:47Z","url":{"current":"james-phelps-md","_type":"slug"},"displayName":"James Phelps, MD","_createdAt":"2020-02-21T11:23:21Z","_rev":"pI9SawGKsTP14Lioy52fLS","_type":"author"}],"gptTakeaways":"• Marissa's symptoms suggest mixed depression or depression with PTSD, complicating diagnosis and treatment decisions.\n\n• Antidepressants and lamotrigine are considered, with lamotrigine offering better tolerability but less obvious applicability.\n\n• Antidepressant withdrawal and lamotrigine allergy risks are compared, influencing treatment choice.\n\n• Patient education and weighing treatment risks are crucial when diagnosis is uncertain.","contentCategory":{"_rev":"snQqhhB4O8T5bi1viURsgs","_type":"contentCategory","name":"Articles","_id":"8bdaa7fc-960a-4b57-b076-75fdce3741bb","_updatedAt":"2020-02-25T09:35:56Z","_createdAt":"2020-02-06T09:15:47Z"},"factCheckAuthorMapping":null,"_id":"d6ba6b71-6f80-43bf-8395-883a2728f7bb","documentGroupMapping":null,"factCheckAuthors":null,"is_visible":true,"body":[{"disableLightBox":true,"_type":"figure","widthP":48,"imgcaption":[{"children":[{"_type":"span","marks":[],"text":"matiasdelcarmine/AdobeStock","_key":"5027ca70270e0"}],"_type":"block","style":"normal","_key":"6cb0638d0561","markDefs":[]}],"asset":{"_ref":"image-7466224b747025da7c84318fef9678a0f34e2c49-3673x2960-jpg","_type":"reference"},"disableTextWrap":false,"alt":"bipolar","_key":"106a481d4f62","alignment":"left"},{"_type":"block","style":"normal","_key":"a22f563e8565","markDefs":[{"href":"https://www.psychiatrictimes.com/topics/major-depressive-disorder","_key":"edf0ac03a5bc","nofollow":true,"blank":true,"_type":"link"},{"_type":"link","href":"https://www.psychiatrictimes.com/topics/sleep-disorders","_key":"4965cd747f01","nofollow":true,"blank":true}],"children":[{"_type":"span","marks":[],"text":"“Marissa” has a history of trauma and ","_key":"7e795a6e1eae0"},{"_type":"span","marks":["edf0ac03a5bc"],"text":"major depressive disorder","_key":"5427360ce6b1"},{"_type":"span","marks":[],"text":" (MDD). She reports feeling anxious and struggling with ","_key":"4f0759149411"},{"_type":"span","marks":["4965cd747f01"],"text":"insomnia","_key":"b95fad16d960"},{"_type":"span","marks":[],"text":". Her partner gently notes that Marissa can be pretty angry sometimes. Marissa could have comorbid MDD and posttraumatic stress disorder (PTSD), or she could have a depressive mixed state (and perhaps PTSD as well). As described in the first essay in this 3-part series, Marissa’s symptoms alone will not differentiate these diagnoses. The last of 4 ways of coping with this diagnostic uncertainty discussed in Part 2, comparing the risks of treatment options, is presented here through Marissa’s case.","_key":"6533e3775a3b"}]},{"_type":"block","style":"normal","_key":"0fba996494ae","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"1ba3bee70f700"}]},{"_type":"block","style":"normal","_key":"ad2f46951b26","markDefs":[{"_type":"link","href":"https://www.psychiatrictimes.com/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2F6516fcf6196099be52f4e555fd8cdbe9b9e604b8-1430x424.jpg%3Ffit%3Dcrop%26auto%3Dformat\u0026w=3840\u0026q=75","_key":"f19d03b3a1df","nofollow":true,"blank":true}],"children":[{"_type":"span","marks":[],"text":"The ","_key":"ecb9243cb3330"},{"marks":["strong","f19d03b3a1df"],"text":"Figure","_key":"ecb9243cb3331","_type":"span"},{"marks":[],"text":" presents the spectrum of mixed states,","_key":"ecb9243cb3332","_type":"span"},{"_type":"span","marks":["superscript"],"text":"1","_key":"5d4ecb3a1e11"},{"text":" the diagnostic dilemma, and a way of thinking about treatment options.","_key":"bd12760aed44","_type":"span","marks":[]}]},{"disableTextWrap":false,"_type":"figure","disableLightBox":true,"_key":"2ca7a4d73fcb","alt":"Figure. The Spectrum of Mixed States","asset":{"_ref":"image-6516fcf6196099be52f4e555fd8cdbe9b9e604b8-1430x424-jpg","_type":"reference"},"widthP":60,"alignment":"right","imgcaption":[{"children":[{"_type":"span","marks":["strong"],"text":"Figure. ","_key":"2a364c834dd20"},{"marks":[],"text":"The Spectrum of Mixed States","_key":"cdb60e349dd9","_type":"span"}],"_type":"block","style":"normal","_key":"24f40f8d3240","markDefs":[]}],"blank":true},{"_type":"block","style":"normal","_key":"b2deed03ef4f","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"92aacbdd3c6c0"}]},{"style":"normal","_key":"29f6fcdbaca3","markDefs":[{"_type":"link","href":"https://www.psychiatrictimes.com/topics/ptsd","_key":"c72c831c2bda","nofollow":true,"blank":true}],"children":[{"marks":[],"text":"Suppose Marissa, who is 28 years old, has a cousin with possible bipolar disorder, had her first episode of depression at age 20 and 2 episodes since, one of which occurred shortly after the birth of her 2-year-old daughter. Sertraline made her insomnia much worse, so she stopped it. These features raise the probability of bipolarity, but only weakly vs (for example) a strong family history, earlier age of onset, more frequent episodes, and a more adverse response to sertraline. The diagnostic question remains: mixed depression or depression with ","_key":"36e5351be6e30","_type":"span"},{"_type":"span","marks":["c72c831c2bda"],"text":"PTSD","_key":"9cbd42080cbf"},{"_type":"span","marks":[],"text":"?","_key":"f83d429f5c34"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"011ba4469c3e0"}],"_type":"block","style":"normal","_key":"fca1ef6e806c"},{"children":[{"_type":"span","marks":[],"text":"After patient education (discussed in Part 2), Marissa understands this differential and prefers a medication approach over psychotherapy (even after digital options are presented). A direct comparison of treatment approaches is warranted.","_key":"2fbdbd75a7e00"}],"_type":"block","style":"normal","_key":"c723e6fccf17","markDefs":[]},{"_key":"fa84f41ebd4c","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"87cf5f9f67cc0"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Antidepressants or Lamotrigine?","_key":"ad5e1574e2b70"}],"_type":"block","style":"normal","_key":"2a939ed1a45e"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Antidepressants are an obvious option for Marissa. They have modest benefits in both depression","_key":"543efd4c87450"},{"_type":"span","marks":["superscript"],"text":"2","_key":"2be77bca8ff7"},{"text":" and PTSD.","_key":"6cc301ed211a","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"3","_key":"bde495c2ec7a"},{"_type":"span","marks":[],"text":" Lamotrigine is not so obvious. Here’s the logic.","_key":"7bdfbeb80edf"}],"_type":"block","style":"normal","_key":"03e8bc05f80e"},{"style":"normal","_key":"43af0cf913eb","markDefs":[],"children":[{"_key":"7bda3815a6030","_type":"span","marks":[],"text":""}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Treatment guidelines for mixed states","_key":"806dbdc007950"},{"_type":"span","marks":["strikethrough"],"text":"4","_key":"f4fdb1e69bbd"},{"_type":"span","marks":[],"text":" are based primarily on efficacy in short-term RCTs funded by pharmaceutical companies in their pursuit of US Food and Drug Administration approval. Older medications are less studied. No randomized trials have been conducted for broadly defined mixed states (see Part 1).","_key":"cb53f95426f8"}],"_type":"block","style":"normal","_key":"1f193cab6eb9"},{"markDefs":[],"children":[{"marks":[],"text":"","_key":"dbf1d41106e50","_type":"span"}],"_type":"block","style":"normal","_key":"b73e150b5645"},{"markDefs":[],"children":[{"_key":"b13a437632a10","_type":"span","marks":[],"text":"Tolerability (adverse effects and long-term risks) frequently determines patients’ choice, rather than highest efficacy, particularly if symptoms are chronic not acute. Lamotrigine has the best tolerability amongst the mood stabilizers with antidepressant effects. (Lurasidone lacks decades of use to fully understand its long-term risks; likewise for lumateperone, cariprazine, and iloperidone. Quetiapine can cause insulin resistance, which appears to contribute to treatment resistance."},{"_type":"span","marks":["superscript"],"text":"5","_key":"019ccde9bdcb"},{"_type":"span","marks":[],"text":" Even low doses of lithium can cause hypothyroidism.","_key":"2edc7e75dde3"},{"_type":"span","marks":["superscript"],"text":"6","_key":"8742b382f81a"},{"marks":[],"text":")","_key":"6a4399bcb80a","_type":"span"}],"_type":"block","style":"normal","_key":"03b178c94582"},{"_key":"c69636a57931","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"fc5c7007498e0"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Extrapolating Treatment Options","_key":"8e91f866e7cc0"}],"_type":"block","style":"normal","_key":"cd783dba1c29"},{"_key":"cc6a6ebd7b49","markDefs":[{"_type":"link","href":"https://www.psychiatrictimes.com/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fpsychtimes%2F6516fcf6196099be52f4e555fd8cdbe9b9e604b8-1430x424.jpg%3Ffit%3Dcrop%26auto%3Dformat\u0026w=3840\u0026q=75","_key":"b08e775e8ebd","nofollow":true,"blank":true}],"children":[{"_type":"span","marks":[],"text":"As shown in the ","_key":"6aa1edca5d450"},{"_type":"span","marks":["strong","b08e775e8ebd"],"text":"Figure","_key":"6aa1edca5d451"},{"marks":[],"text":", by extrapolating from experience in MDD, antidepressants can be considered for mixed depressions. Likewise, by extrapolating from experience in bipolar II, lamotrigine can also be considered.","_key":"6aa1edca5d452","_type":"span"}],"_type":"block","style":"normal"},{"children":[{"_type":"span","marks":[],"text":"","_key":"5deb7c538fed0"}],"_type":"block","style":"normal","_key":"66ef1f58aae4","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Many practitioners are hesitant to consider lamotrigine unless a history of hypomania or mania is obtained. Indeed, while it makes sense to consider antidepressants for depression comorbid with PTSD or generalized anxiety disorder; there is no obvious reason to consider lamotrigine for these conditions—","_key":"476898db106a0"},{"_key":"476898db106a1","_type":"span","marks":["em"],"text":"except when a depressive mixed state is"},{"_type":"span","marks":[],"text":" ","_key":"476898db106a2"},{"_type":"span","marks":["em"],"text":"equally likely the correct diagnosis","_key":"476898db106a3"},{"_type":"span","marks":[],"text":".","_key":"476898db106a4"}],"_type":"block","style":"normal","_key":"d5b7da354092"},{"markDefs":[],"children":[{"_key":"91f1e5526fb70","_type":"span","marks":[],"text":"Marissa has surely heard of antidepressants. The patient education discussed in Part 2 will help her understand why lamotrigine is also an option. Now, compare their risks."}],"_type":"block","style":"normal","_key":"0c404d5d9731"},{"style":"normal","_key":"d83c9a09f76f","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"1e114e8abd5a0"}],"_type":"block"},{"_type":"block","style":"normal","_key":"1393f71c02e9","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Comparing Major Risks","_key":"05edbe0d4a570"}]},{"_key":"f4ef953c49dd","markDefs":[],"children":[{"_key":"44a536ceab3e0","_type":"span","marks":[],"text":"The efficacy of antidepressants vs lamotrigine in broadly defined mixed states has not been studied. But two tolerability concerns are well known: antidepressant withdrawal and lamotrigine allergy. Understanding these risks may have a strong impact on treatment choice when diagnosis is uncertain."}],"_type":"block","style":"normal"},{"children":[{"_type":"span","marks":[],"text":"","_key":"90419e037c460"}],"_type":"block","style":"normal","_key":"5b2d958b5eda","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Patients often weigh these risks very differently. For some, hearing the risk of Stevens-Johnson Syndrome (SJS) precludes any further consideration, regardless of how one explains its incidence. For others who may have known someone who struggled to discontinue their antidepressant, concerns about withdrawal might strongly affect their treatment choice.","_key":"d125a9d56d260"}],"_type":"block","style":"normal","_key":"20ffdaacc454"},{"_type":"block","style":"normal","_key":"b5ad5791878c","markDefs":[],"children":[{"text":"","_key":"61369c75509e0","_type":"span","marks":[]}]},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Incidence of Severe Antidepressant Withdrawal","_key":"db6bafd86f7c0"}],"_type":"block","style":"normal","_key":"af347c3875db"},{"_type":"block","style":"normal","_key":"4e99b7b89be1","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Different sources estimate very different rates of severe withdrawal. In one podcast interview, academic psychiatrist Michael Thase suggested an incidence of 1% to 2%.","_key":"da877787f1940"},{"text":"7","_key":"3772e72c011d","_type":"span","marks":["superscript"]},{"_type":"span","marks":[],"text":" Other authors, including those of a review of data published through 2022,","_key":"48aad7c98ca9"},{"_type":"span","marks":["superscript"],"text":"8","_key":"8791886a2187"},{"_type":"span","marks":[],"text":" believe the rate is much higher, at least 10% (Mark Horowitz, personal communication). That review notes important effects of dose, duration of treatment, and differences between antidepressants. Obviously, the definition of “severe” also affects rates.","_key":"f41020550da7"}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"7e8abe0f298e0"}],"_type":"block","style":"normal","_key":"36bf88991a3c"},{"style":"normal","_key":"1ffc088e8e34","markDefs":[],"children":[{"_type":"span","marks":[],"text":"A 2024 review of 79 studies found a 3% rate of severe withdrawal (higher for venlafaxine, desvenlafaxine and escitalopram).","_key":"be355eecfa340"},{"_type":"span","marks":["superscript"],"text":"9","_key":"57374b827bec"},{"_key":"cbd52f6a3b5b","_type":"span","marks":[],"text":" Lastly, a post-hoc analysis of a recent randomized trial of antidepressant discontinuation found a rate of significant withdrawal of 16% (4 or more emergent symptoms, but not necessarily “severe”; see Response to a Comment by Horowitz)."},{"_type":"span","marks":["superscript"],"text":"10","_key":"6e6dace49d60"}],"_type":"block"},{"children":[{"_type":"span","marks":[],"text":"","_key":"1f972ea23ec60"}],"_type":"block","style":"normal","_key":"096653bbb12c","markDefs":[]},{"children":[{"marks":["strong"],"text":"Withdrawal vs Stevens-Johnson Syndrome","_key":"1520ab2300ba0","_type":"span"}],"_type":"block","style":"normal","_key":"6a044b590b38","markDefs":[]},{"_key":"f3e70f58d6b1","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Comparing antidepressant withdrawal and extreme allergic reactions to lamotrigine is obviously like comparing apples and oranges. Nevertheless, for a very rough impression of relative risk, comparing their rates may be useful. Consider first their lowest respective estimates: 1% for withdrawal; a 0.05% incidence of SJS","_key":"1ccc36d511040"},{"_type":"span","marks":["superscript"],"text":"11","_key":"56960fd8153e"},{"_type":"span","marks":[],"text":"; and a 0.05% incidence of death among patients with SJS.","_key":"938fe3ddbf8e"},{"_type":"span","marks":["superscript"],"text":"12","_key":"b9dd11684154"},{"marks":[],"text":" Using these figures, the rate of severe antidepressant withdrawal is 20 times that of SJS and 400 times the SJS death rate.","_key":"79cc2f2f0f2c","_type":"span"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"da1b073d72160"}],"_type":"block","style":"normal","_key":"66bcb625881c"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Or consider the highest respective estimates: 10% for severe withdrawal, and 1% for SJS (inaccurate, but oft cited on internet sites). Using these figures, severe withdrawal is 100 times more common than SJS and 500 times the SJS death rate. Severe withdrawal has been associated with suicidal ideation, but not death by suicide.","_key":"d84da16105020"},{"_type":"span","marks":["superscript"],"text":"13","_key":"54b2dde04a8f"},{"text":" On the other hand, very severe withdrawal can be life-limiting for months to years, as attested by thousands of online accounts.","_key":"b22c4b2610a0","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"14","_key":"0792677bf0d5"}],"_type":"block","style":"normal","_key":"2382edceedf9"},{"children":[{"_type":"span","marks":[],"text":"","_key":"d1245bfe2e6e0"}],"_type":"block","style":"normal","_key":"24d667ac5bc6","markDefs":[]},{"children":[{"_type":"span","marks":[],"text":"Marissa has yet to make her decision between these 2 options. You will have to be prepared to assist her.","_key":"2ca1cecd2a2e0"}],"_type":"block","style":"normal","_key":"27dcfd896a12","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"b58fc94753a60"}],"_type":"block","style":"normal","_key":"3fb6413aa679"},{"_key":"507473af0c6d","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Concluding Thoughts","_key":"e9907069aca90"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"When patients present with depression and “The 4 A’s” (anxiety, anger, agitation, and/or attention problems), differential diagnosis is challenging. Clinicians should maintain an open mind regarding alternative explanations until good outcomes are obtained. Four means of coping with the resultant diagnostic uncertainty have been presented in this 3-part series.","_key":"9e37df45c5650"}],"_type":"block","style":"normal","_key":"c96955c8be6b"},{"children":[{"_key":"4b92e93eee0b0","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal","_key":"87f56ea29997","markDefs":[]},{"markDefs":[{"href":"https://wwnorton.com/books/A-Spectrum-Approach-to-Mood-Disorders/","_key":"1ace03e4fbea","_type":"link"},{"_type":"link","href":"https://wwnorton.com/books/Bipolar-Not-So-Much/","_key":"a859b5c0de4e"}],"children":[{"text":"Dr Phelps","_key":"7877edd9797d0","_type":"span","marks":["strong"]},{"_key":"7877edd9797d1","_type":"span","marks":[],"text":" "},{"text":"is retiring from 30 years of treating complex mood disorders, and recently founded another website, DepressionEducation.org. He is the bipolar disorder section editor for ","_key":"7877edd9797d2","_type":"span","marks":["em"]},{"_type":"span","marks":[],"text":"Psychiatric Times®","_key":"7877edd9797d3"},{"_type":"span","marks":["em"],"text":" and the author of","_key":"7877edd9797d4"},{"text":" ","_key":"7877edd9797d5","_type":"span","marks":[]},{"_type":"span","marks":["1ace03e4fbea"],"text":"A Spectrum Approach to Mood Disorders","_key":"7877edd9797d6"},{"_type":"span","marks":["em"],"text":" for clinicians and","_key":"7877edd9797d7"},{"marks":[],"text":" ","_key":"7877edd9797d8","_type":"span"},{"marks":["a859b5c0de4e"],"text":"Bipolar, Not So Much","_key":"7877edd9797d9","_type":"span"},{"_type":"span","marks":[],"text":" ","_key":"7877edd9797d10"},{"_type":"span","marks":["em"],"text":"for patients and their families","_key":"7877edd9797d11"},{"marks":[],"text":".","_key":"7877edd9797d12","_type":"span"}],"_type":"block","style":"normal","_key":"9d92e0e947a4"},{"children":[{"_type":"span","marks":[],"text":"","_key":"c2de1efac71c0"}],"_type":"block","style":"normal","_key":"1d6afdeb5000","markDefs":[]},{"_key":"09ff24887482","markDefs":[],"children":[{"_key":"a36ff4fc70cb0","_type":"span","marks":["strong"],"text":"References"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"dceb60e768b1","markDefs":[{"_key":"9b26d8748925","blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/28421980/"}],"children":[{"_type":"span","marks":[],"text":"1. Stahl SM, Morrissette DA, Faedda G, et al. ","_key":"08c068792bd00"},{"text":"Guidelines for the recognition and management of mixed depression.","_key":"08c068792bd01","_type":"span","marks":["9b26d8748925"]},{"marks":[],"text":" ","_key":"f302efca0013","_type":"span"},{"_key":"08c068792bd02","_type":"span","marks":["em"],"text":"CNS Spectr"},{"_type":"span","marks":[],"text":". 2017;22(2):203-219.","_key":"08c068792bd03"}]},{"_key":"b1a15ee73baf","markDefs":[{"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/29477251/","_key":"408441d8ddfb","blank":true}],"children":[{"_key":"00fa1fc2fc320","_type":"span","marks":[],"text":"2. Cipriani A, Furukawa TA, Salanti G, et al. "},{"_type":"span","marks":["408441d8ddfb"],"text":"Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis.","_key":"00fa1fc2fc321"},{"_key":"a20a729eaf83","_type":"span","marks":[],"text":" "},{"_type":"span","marks":["em"],"text":"Lancet","_key":"00fa1fc2fc322"},{"marks":[],"text":". 2018;391(10128):1357-1366.","_key":"00fa1fc2fc323","_type":"span"}],"_type":"block","style":"normal"},{"markDefs":[{"blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/38869978/","_key":"643d4d15c6c8"}],"children":[{"_type":"span","marks":[],"text":"3. Guidetti C, Feeney A, Hock RS, et al. ","_key":"e0fa411b9d820"},{"_type":"span","marks":["643d4d15c6c8"],"text":"Antidepressants in the acute treatment of post-traumatic stress disorder in adults: a systematic review and meta-analysis.","_key":"e0fa411b9d821"},{"_type":"span","marks":[],"text":" ","_key":"f17e3a426898"},{"_type":"span","marks":["em"],"text":"Int Clin Psychopharmacol","_key":"e0fa411b9d822"},{"_type":"span","marks":[],"text":". 2024.","_key":"e0fa411b9d823"}],"_type":"block","style":"normal","_key":"995a0c827b5e"},{"_type":"block","style":"normal","_key":"e9e7365f118a","markDefs":[{"blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/35053835/","_key":"8c739eb8922f"}],"children":[{"_type":"span","marks":[],"text":"4. Natale A, Mineo L, Fusar-Poli L, et al. ","_key":"4eb6be63d1640"},{"_type":"span","marks":["8c739eb8922f"],"text":"Mixed depression: a mini-review to guide clinical practice and future research developments.","_key":"4eb6be63d1641"},{"_key":"8a6883cd96da","_type":"span","marks":[],"text":" "},{"text":"Brain Sci","_key":"4eb6be63d1642","_type":"span","marks":["em"]},{"_type":"span","marks":[],"text":". 2022;12(1):92.","_key":"4eb6be63d1643"}]},{"style":"normal","_key":"1a16d566767d","markDefs":[{"_key":"ad9727862d87","blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/35120288/"}],"children":[{"marks":[],"text":"5. Calkin CV, Chengappa KR, Cairns K, et al. ","_key":"39a3f4bdecae0","_type":"span"},{"_type":"span","marks":["ad9727862d87"],"text":"Treating insulin resistance with metformin as a strategy to improve clinical outcomes in treatment-resistant bipolar depression (the TRIO-BD Study): a randomized, quadruple-masked, placebo-controlled clinical trial.","_key":"39a3f4bdecae1"},{"_type":"span","marks":[],"text":" ","_key":"f8d36a48ed08"},{"text":"J Clin Psychiatry","_key":"39a3f4bdecae2","_type":"span","marks":["em"]},{"_type":"span","marks":[],"text":". 2022;83(2):21m14022.","_key":"39a3f4bdecae3"}],"_type":"block"},{"markDefs":[{"blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/37704933/","_key":"5982e74453aa"}],"children":[{"_key":"d5b024649e080","_type":"span","marks":[],"text":"6. Phelps J, Coskey OP. "},{"_type":"span","marks":["5982e74453aa"],"text":"Low and very low lithium levels: thyroid effects are small but still require monitoring.","_key":"d5b024649e081"},{"_key":"ccf7ce065454","_type":"span","marks":[],"text":" "},{"_type":"span","marks":["em"],"text":"Bipolar Disord","_key":"d5b024649e082"},{"_type":"span","marks":[],"text":". 2024;26(2):129-135.","_key":"d5b024649e083"}],"_type":"block","style":"normal","_key":"e978bf17a068"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"7. Thase M. Webinar, Psychopharmacology Institute. Response to Listener Question. May 7, 2020.","_key":"40755f243fb20"}],"_type":"block","style":"normal","_key":"87080d705305"},{"_type":"block","style":"normal","_key":"e89f4f4e6cb7","markDefs":[{"blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/36513909/","_key":"bd468ed062b3"}],"children":[{"text":"8. Horowitz MA, Framer A, Hengartner MP, et al. ","_key":"9fb2053bb80f0","_type":"span","marks":[]},{"_type":"span","marks":["bd468ed062b3"],"text":"Estimating risk of antidepressant withdrawal from a review of published data.","_key":"9fb2053bb80f1"},{"_type":"span","marks":[],"text":" ","_key":"1a4f8c802cc8"},{"_type":"span","marks":["em"],"text":"CNS Drugs","_key":"9fb2053bb80f2"},{"_type":"span","marks":[],"text":". 2023;37(2):143-157.","_key":"9fb2053bb80f3"}]},{"style":"normal","_key":"2282445ded56","markDefs":[{"href":"https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(24)00133-0/fulltext","_key":"d6033e1948a1","blank":true,"_type":"link"}],"children":[{"_type":"span","marks":[],"text":"9. Henssler J, Schmidt Y, Schmidt U, et al. 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","body":[{"_type":"iframe","_key":"e0daab4b5bff","url":"https://embeds.audioboom.com/posts/7956631/embed/v4"},{"_key":"956770a0403a","markDefs":[],"children":[{"marks":["strong"],"text":"PSYCHPEARLS PODCAST","_key":"d75d626c5b02","_type":"span"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"76cd2ca056e0","markDefs":[],"children":[{"text":"Last month we taught you how evening light can worsen mood. Today we teach you how to fix that. ","_key":"f398087e7e99","_type":"span","marks":[]}]},{"_type":"block","style":"normal","_key":"37ad5d7c5898","markDefs":[],"children":[{"text":"Welcome to ","_key":"307978b0fb6d","_type":"span","marks":[]},{"_type":"span","marks":["em"],"text":"PsychPearls","_key":"d22275f30f90"},{"_type":"span","marks":[],"text":" podcast with ","_key":"f61a809e25ea"},{"text":"Psychiatric Times","_key":"1dffba05e306","_type":"span","marks":["em"]},{"_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.","_key":"505e9f6a73b8"}]},{"markDefs":[],"children":[{"text":"I’m Chris Aiken, the Mood Disorders Section Editor for ","_key":"dfdf9b7a3005","_type":"span","marks":[]},{"marks":["em"],"text":"Psychiatric Times","_key":"153f3cb4c790","_type":"span"},{"_type":"span","marks":["superscript"],"text":"TM","_key":"4e1162c083bd"},{"marks":[],"text":" and the editor-in-chief of the ","_key":"5bc89361d862","_type":"span"},{"_type":"span","marks":["em"],"text":"Carlat Psychiatry Report","_key":"27999f96f295"},{"_type":"span","marks":[],"text":", and I’m Kellie Newsome, a psychiatric NP and the cohost of the ","_key":"f3f5cd4b23da"},{"_type":"span","marks":["em"],"text":"Carlat Psychiatry Podcast","_key":"76f7861900c8"},{"_type":"span","marks":[],"text":".","_key":"e3cfb7c5a28d"}],"_type":"block","style":"normal","_key":"a5857dd88911"},{"_type":"block","style":"normal","_key":"f185b3ff09da","markDefs":[{"_type":"link","href":"https://www.psychiatrictimes.com/view/blue-light-depression-bipolar-disorder","_key":"9875423f7f6f","blank":true},{"blank":true,"_type":"link","href":"https://www.ncbi.nlm.nih.gov/pubmed/23926261","_key":"5821d87ef1f6"}],"children":[{"marks":["strong"],"text":"KELLIE NEWSOME","_key":"9a0f2316a98a0","_type":"span"},{"_key":"9a0f2316a98a1","_type":"span","marks":[],"text":": Evening light worsens sleep and mood, and "},{"_type":"span","marks":["9875423f7f6f"],"text":"last August","_key":"9a0f2316a98a2"},{"text":" we unraveled the biology behind that association. To recap, evening light – particularly the blue wavelength suppresses melatonin, worsening 2 systems that are already fragile in people with mood disorders: sleep and circadian rhythms. In animal studies it even altered the core architecture of the brain – shrinking the dendritic spines that ","_key":"9a0f2316a98a3","_type":"span","marks":[]},{"text":"help us learn","_key":"19d78f18d668","_type":"span","marks":["5821d87ef1f6"]},{"_type":"span","marks":[],"text":" while we sleep.","_key":"ad5adf21833b"},{"text":"1","_key":"08cd09f661b3","_type":"span","marks":["superscript"]}]},{"children":[{"_type":"span","marks":[],"text":"But you don’t have to go into the woods and live deliberately to fix this problem. Today, we’ll teach you how to use blue light filters to stabilize the circadian rhythms that regulate mood and sleep, and how to use them in ","_key":"e45918effa9b0"},{"_type":"span","marks":["1198bbed81a5"],"text":"dark therapy","_key":"299805087023"},{"_type":"span","marks":[],"text":", a behavioral therapy for mania.","_key":"3575cf901bec"},{"_type":"span","marks":["superscript"],"text":"2","_key":"f2efb30b51eb"}],"_type":"block","style":"normal","_key":"74c64a3be23f","markDefs":[{"blank":true,"_type":"link","href":"https://www.ncbi.nlm.nih.gov/pubmed/27226262","_key":"1198bbed81a5"}]},{"_type":"block","style":"normal","_key":"baf9da45e634","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Blue Light and Lunar Cycles","_key":"468b1c6ce26c0"}]},{"style":"normal","_key":"069af0e50d8d","markDefs":[],"children":[{"text":"CHRIS AIKEN","_key":"2dcff61dce8d0","_type":"span","marks":["strong"]},{"marks":[],"text":": There are 2 well-known photoreceptors in the eye. The rods see black and white, and the cones add color vision. But in the 1990s a new photoreceptor was discovered – melanopsin – which only responds to the blue wavelength of light. This photoreceptor doesn’t help us see, but it does regulate our circadian rhythm. In the past, this system worked well because we didn’t have much blue light in the evening. There were candles, starlight, fireplaces – all yellow light.","_key":"2dcff61dce8d1","_type":"span"}],"_type":"block"},{"style":"normal","_key":"7641e7f4c6d3","markDefs":[{"href":"https://pubmed.ncbi.nlm.nih.gov/32252567/","_key":"fe0f92d0923b","blank":true,"_type":"link"}],"children":[{"_type":"span","marks":["strong"],"text":"KELLIE NEWSOME","_key":"943378cefa1b0"},{"_type":"span","marks":[],"text":": Except once a month when the blue moon was full. And it’s no coincidence the word lunatic arose in the middle ages as a term for mental illness. It was believed that some people went into temporary bouts of insanity that followed the lunar cycle – the moon. Seven hundred years later, ","_key":"943378cefa1b1"},{"_type":"span","marks":["fe0f92d0923b"],"text":"reports","_key":"8c8c27f27800"},{"_type":"span","marks":[],"text":" linking the full moon to worsening of psychiatric disorders continue to roll in.","_key":"5c3799391272"},{"marks":["superscript"],"text":"3","_key":"e0312ad21686","_type":"span"}],"_type":"block"},{"markDefs":[],"children":[{"marks":["strong"],"text":"Blue Light Blockers","_key":"22afb4f3c5e90","_type":"span"}],"_type":"block","style":"normal","_key":"52e54edb5332"},{"markDefs":[],"children":[{"text":"CHRIS AIKEN","_key":"700b98cbf4f20","_type":"span","marks":["strong"]},{"_key":"700b98cbf4f21","_type":"span","marks":[],"text":": And in today’s world, every night is a full moon, because cell phones, plasma TVs, and energy efficient bulbs emit a lot of blue light. But technology has also come to the rescue in the form of blue light filtering glasses. These are amber colored glasses, and when you wear them they filter out close to 100% of blue light. They’ve gained popularity among sports figures and celebrities, because wearing them at night improves sleep – which then raises cognitive and athletic performance. But most models out there do not filter enough blue light to make a meaningful difference in psychiatric disorders. We recommend the glasses that were used in the clinical research – and there are 2 types. Some studies have used Uvex glasses, eg Uvex Skyper S1933X and Uvex Ultra-spec 2000, which are $10 to 15 dollars on Amazon."},{"_type":"span","marks":["strong"],"text":" ","_key":"285651f59c0a"},{"_type":"span","marks":[],"text":"Another option is lowbluelights.com.","_key":"46a5e7d06801"},{"_type":"span","marks":["strong"],"text":" ","_key":"11eb94fabb93"},{"_type":"span","marks":[],"text":"Any pair on that site will work, and these are much better quality for a higher price, around $50.","_key":"66ffc53ae5a8"}],"_type":"block","style":"normal","_key":"e2613fe8d544"},{"style":"normal","_key":"78d6c8e5e7e9","markDefs":[],"children":[{"_key":"9c694a732b9b0","_type":"span","marks":["strong"],"text":"KELLIE NEWSOME"},{"marks":[],"text":": I keep a pair of these glasses at my desk for patients to try on. They’re usually surprised to see the world looks quite pleasant through them. They don’t make things dark, but give the world a relaxing, yellow hue. Some patients find them so soothing that I have to warn patients not to wear them during the day, because doing so will flip their circadian rhythm in the wrong direction. When you wear them, your brain will think it’s in pitch darkness, and we only want that effect at night.","_key":"9c694a732b9b1","_type":"span"}],"_type":"block"},{"children":[{"_type":"span","marks":["strong"],"text":"CHRIS AIKEN","_key":"1a20ca278b3c0"},{"text":": Wearing them has real biological effects. When you put them on, your melatonin starts to rise, the same as it does in a ","_key":"1a20ca278b3c1","_type":"span","marks":[]},{"_type":"span","marks":["12575d5be836"],"text":"pitch-dark room","_key":"390d3a981cbc"},{"_type":"span","marks":[],"text":".","_key":"91282980cf2d"},{"_type":"span","marks":["superscript"],"text":"4","_key":"697961003892"},{"text":" Sometimes patients ask if they can just take melatonin instead, but that doesn’t have the same effect. In a recent randomized controlled trial, taking artificial melatonin did nothing to stabilize mood in bipolar disorder.","_key":"c6dff41e430d","_type":"span","marks":[]},{"_key":"2599727d60a1","_type":"span","marks":["superscript"],"text":"5"},{"_key":"555373281736","_type":"span","marks":[],"text":" So it’s not enough to have melatonin drizzled on the brain. There are other biological effects involved in pumping out the brain’s indigenous melatonin that are necessary here."}],"_type":"block","style":"normal","_key":"59a191d00673","markDefs":[{"blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/15713707/","_key":"12575d5be836"}]},{"_type":"block","style":"normal","_key":"c7d38350dc8b","markDefs":[{"blank":true,"_type":"link","href":"https://www.psychiatrictimes.com/view/blue-light-depression-bipolar-disorder","_key":"c8e9043c10b4"}],"children":[{"_type":"span","marks":[],"text":"If you want to know more about the biological effects of light and darkness listen to our August 2nd podcast on ","_key":"c82b3a5ff5f60"},{"_key":"c82b3a5ff5f61","_type":"span","marks":["c8e9043c10b4"],"text":"Blue Light, Depression, and Bipolar Disorder"},{"text":". Now, let’s move on to the clinical research.","_key":"c82b3a5ff5f62","_type":"span","marks":[]}]},{"_type":"block","style":"normal","_key":"79f7a0caf625","markDefs":[],"children":[{"_key":"d63f0e30dbe20","_type":"span","marks":["strong"],"text":"Origins of Dark Therapy"}]},{"markDefs":[{"blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/7512910/","_key":"b2f2bf6e15cb"}],"children":[{"_type":"span","marks":["strong"],"text":"KN","_key":"d47c38c77a240"},{"marks":[],"text":": In the 1980s Thomas Wehr, MD, and Norman Rosenthal, MD, made a surprise discovery while working at the National Institute of Mental Health (NIMH). Some patients had worsened depression in the wintertime that improved with light therapy. Their research suggested that circadian rhythms played a strong role in mood disorders, something that was already hinted at by the high rates of insomnia in major depression and the fact that a night without sleep often triggered an episode of mania. So, Wehr turned his attention from morning light to evening darkness. He began with normal subjects and placed them in a pitch-dark room for 14 hours overnight, imitating a dark winter night where the sun goes down at 6 PM and rises at 8 AM. The subjects were a little sleep deprived before the experiment, getting about 7 hours per night, something Wehr thought might be due to the artificial evening light of modern life. After a few weeks in the dark bedroom, their ","_key":"d47c38c77a241","_type":"span"},{"text":"sleep stabilized","_key":"5640001f0a8e","_type":"span","marks":["b2f2bf6e15cb"]},{"_key":"78be0d17874c","_type":"span","marks":[],"text":" to 8 hours and 15 minutes per night, closer to the recommended amount an adult needs."},{"_type":"span","marks":["superscript"],"text":"6,7","_key":"456071b75d5a"}],"_type":"block","style":"normal","_key":"d79872329c72"},{"_key":"4e8d605914a3","markDefs":[{"blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/9611672/","_key":"0ed721ba65fa"}],"children":[{"_type":"span","marks":["strong"],"text":"CA","_key":"248c11caaf5c0"},{"_type":"span","marks":[],"text":": Then in 1994 a man came to the NIMH seeking help for rapid cycling bipolar disorder. Most patients don’t call up the NIMH to get help, so we can imagine this man had a pretty bad case. He was a successful engineer with a hyperthymic temperament, but in his 40s he became depressed and started fluoxetine and nortriptyline. He got better on this combination, but then went into a 4-year bout of rapid cycling moods cycling in and out of depression and hypomania every 1 to 2 months. Mood stabilizers did not help, so he came to the NIMH. Wehr knew that sleep disruption could trigger rapid cycling, and he wondered if his super-dark room could stabilize it. He put the patient through the same protocol he used for sleep, placing him in a pitch dark room for 14 hours each night. With this dark therapy, he improved so rapidly that they eased the schedule from 14 hours of darkness to 10 hours each night (10:00 PM to 8:00 AM). He stayed well with that regimen, and that is how dark therapy was ","_key":"248c11caaf5c1"},{"_type":"span","marks":["0ed721ba65fa"],"text":"born","_key":"7b881f4d97bb"},{"marks":[],"text":".","_key":"acda32c28c17","_type":"span"},{"_type":"span","marks":["superscript"],"text":"7","_key":"29d23936e285"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"52ef0cf3e93f","markDefs":[],"children":[{"text":"KN","_key":"28fdb6c254e70","_type":"span","marks":["strong"]},{"_type":"span","marks":[],"text":": But the treatment didn’t really take off. First, it’s hard to get patients in a pitch-dark room overnight. We’re talking so dark that you can’t see your hands in front of your face. Second, we need more than an intriguing case report to put this into practice. The first problem was resolved in the early 2000s by James Phelps, MD.","_key":"28fdb6c254e71"}]},{"_type":"block","style":"normal","_key":"78971994f42f","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Phelps was working in private practice in Oregon when he chanced upon 3 discoveries that would open up new therapeutic doors in bipolar disorder. First, he learned about Wehr’s research on dark therapy. Then he learned about the new photoreceptor, melanopsin, that set the circadian rhythm by responding to blue light. He wondered if dark therapy could be accomplished by blocking only the blue wavelength of light, and that brought him to the third piece of the puzzle: blue light filtering glasses. Other fields of medicine had already raised alarms about the hazards of evening blue light (such as increased risk of cancer and heart disease) and a company was manufacturing these to improve sleep and health. Phelps called this ","_key":"9749394b1d240"},{"_type":"span","marks":["em"],"text":"virtual darkness","_key":"9749394b1d241"},{"_type":"span","marks":[],"text":" and tried the glasses out on his patients. For some, the glasses did nothing, but about half of his patients reported their sleep was better when they wore the glasses 1 to 2 hours before bed.","_key":"9749394b1d242"},{"text":"8","_key":"065994221bfc","_type":"span","marks":["superscript"]}]},{"style":"normal","_key":"390955093fb9","markDefs":[],"children":[{"_key":"03ea9e517e010","_type":"span","marks":[],"text":"He then discovered that welders used the same blue-light filters to protect their eyes at the local welding shop, and this opened the door to more treatments because these factory grade lenses were only $7. Phelps tested them and the fit the bill. "},{"_key":"572dbf06ea9e","_type":"span","marks":["em"],"text":"Consumer Reports "},{"_type":"span","marks":[],"text":"later ran tests of blue light blockers and also concluded that the Uvex safety lenses he was using were among the strongest filters.","_key":"186d9f90286e"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Phelps tested the waters, but the definitive study was a full-scale randomized trial in patients who were hospitalized for mania. In addition to treatment as usual, half wore amber lenses in the evening, and half wore (placebo) gray lenses, until sleeping in a pitch-dark room. The improvements were dramatic over the first week, with a large effect size of 1.9, while the control group barely changed.","_key":"fec10e0ca0740"},{"_key":"8839f67a375e","_type":"span","marks":["superscript"],"text":"2"}],"_type":"block","style":"normal","_key":"71ea429c2694"},{"_key":"cc6b6fdc0b3d","markDefs":[],"children":[{"marks":["strong"],"text":"The Protocol","_key":"1394ceb614ae0","_type":"span"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"You don’t need to be in the hospital to do this therapy. Phelps has had success using it in an outpatient practice, and we have as well. Here’s how you do it.","_key":"30bfbe3945da0"}],"_type":"block","style":"normal","_key":"596761a4cde7"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"The original protocol required manic patients to be in either pitch darkness or virtual darkness (that is, with the amber glasses on) for 14 hours, from 6:00 PM to 8:00 AM. It took about a week for the mania to improve, and as it did the protocol was relaxed a bit, from 14 hours per night to 10 hours per night. So instead of putting the glasses on at 6 PM, they’d put them on at 7:00 PM, then 8:00 PM, and for prevention thy would move it to 9 or 10 PM. They don’t wear the glasses while asleep. That’s what the pitch-dark bedroom is for. But they do put them on if they are awake and the lights are on.","_key":"4cd04c50e02d0"}],"_type":"block","style":"normal","_key":"0c4add95764a"},{"children":[{"_type":"span","marks":[],"text":"And the pitch darkness really does matter. Even light as dim as a nightlight on can interfere with melatonin secretion. In a large epidemiologic study of older adults, sleeping with a night light on doubled the risk of depression over 2 years compared to a pitch-dark bedroom.","_key":"da5c4ea963040"},{"_type":"span","marks":["superscript"],"text":"9","_key":"352455f41630"}],"_type":"block","style":"normal","_key":"c3741b08e60d","markDefs":[]},{"markDefs":[{"blank":true,"_type":"link","href":"http://www.shiftshade.com/","_key":"1ce054c35f5b"}],"children":[{"text":"But how do they get their bedroom pitch dark in this electric light world? ","_key":"e1b57027dcc10","_type":"span","marks":[]},{"text":"Black out curtains","_key":"e1b57027dcc11","_type":"span","marks":["1ce054c35f5b"]},{"_type":"span","marks":[],"text":", electrical tape over LEDs, towels or draft snakes under doors, or sleeping in the basement. If there is still stray light, patients can also sleep with a good eye mask.","_key":"e1b57027dcc12"}],"_type":"block","style":"normal","_key":"97b2fbfacdec"},{"markDefs":[],"children":[{"_key":"d49119795ed50","_type":"span","marks":["strong"],"text":"CA"},{"_type":"span","marks":[],"text":": One problem we run into is patients who feel they can’t sleep without the TV on. Usually the reason is depressive rumination. These patients rely on the TV to distract them from their negative, ruminating thoughts. If that’s the case, we recommend ambient music or boring audiobooks instead. Another problem is patients who are afraid of the dark, such as those with PTSD. Here we have a technological solution. They can use amber colored nightlights that don’t emit any blue light. They are available for around $12.","_key":"d49119795ed51"}],"_type":"block","style":"normal","_key":"8273b2575cc1"},{"_type":"block","style":"normal","_key":"be6037e19876","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"KN","_key":"350baa9963580"},{"_key":"350baa9963581","_type":"span","marks":[],"text":": One modification we don’t recommend is to rely on blue-light filters on laptops and cell phones. Most devices have a setting that turns down the blue in the evening, and no doubt this is certainly a good thing and we’d recommend it in conjunction with dark therapy, but it doesn’t filter 100% and it isn’t going to take care of the background lights. You can find this feature in your smart phone’s settings, or if you’re using a laptop try downloading f.lux (spell it out) for windows or Candlelight by Oliver Denman for Mac."}]},{"style":"normal","_key":"4686c1580b2e","markDefs":[],"children":[{"marks":[],"text":"But what if your patient can’t put the glasses on at 6 PM? Remember the 14-hour protocol was used for hospitalized mania, and they loosened it up as the patient got better. In practice, you might use dark therapy for hypomania, mild mixed states or as an intervention for early signs of mania. In those cases, putting the glasses on 2 hours before bed might be enough.","_key":"4d197f0fc8a80","_type":"span"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"CA","_key":"08f2c9b1d95b0"},{"marks":[],"text":": It’s also important to set up expectations. Tell your patient that dark therapy is going to help stabilize their mood, but it may not help them fall asleep. Here’s an interesting pearl from that controlled trial. The patients who got better with the dark therapy didn’t actually sleep more. They slept a little less than the placebo group, but their sleep did get more regular. It went from sleeping and waking at random times to a more steady, stable circadian pattern.","_key":"08f2c9b1d95b1","_type":"span"},{"_type":"span","marks":["superscript"],"text":"2","_key":"fdeda177bab5"},{"_type":"span","marks":[],"text":" A lot of times patients will give up on dark therapy because they think it is supposed to help them sleep.","_key":"a32bdea71870"}],"_type":"block","style":"normal","_key":"e7257a6d8b9d"},{"markDefs":[],"children":[{"text":"Dark Therapy for Insomnia","_key":"48c1d1ea6fac0","_type":"span","marks":["strong"]}],"_type":"block","style":"normal","_key":"b5c98c8d3194"},{"children":[{"marks":["strong"],"text":"KN","_key":"c513a824ead30","_type":"span"},{"_key":"c513a824ead31","_type":"span","marks":[],"text":": Dark therapy improves mania, but what does it do to sleep? We found 3 randomized controlled trials that tested them out in insomnia, and they had a large effect, helping patients stay asleep longer, fall asleep earlier, and deepening sleep quality."},{"text":"10-12","_key":"8e57359618ec","_type":"span","marks":["superscript"]},{"text":" One of them used the blue light blockers as an adjunct to CBT-insomnia, where half the patients had the behavioral therapy with placebo glasses and half used the blue-light blockers. Not only did sleep improve with the blockers, but so did anxiety and depression.10 Another study looked at performance on cognitive tests after wearing the glasses, and that got better as well, probably because the patients were sleeping better.","_key":"cd9d39970f97","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"11","_key":"0f8658398107"},{"_type":"span","marks":[],"text":" In the sleep studies, patients put the glasses on 1.5 to 2 hours before bedtime.","_key":"98a0034680a3"}],"_type":"block","style":"normal","_key":"e5c617dea0f8","markDefs":[]},{"style":"normal","_key":"c7b0aabbd537","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Blue light blockers have been used successfully in jet lag, and they tend to help night owls fall asleep earlier.","_key":"fa05ef5e016d0"}],"_type":"block"},{"style":"normal","_key":"5bbc20f2c723","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"CA","_key":"08b9b8d0af4d0"},{"text":": I wear them myself and I can attest to that. I’m more patient and have better attention, a little quicker on my feet, the next day if I wore them before bed.","_key":"08b9b8d0af4d1","_type":"span","marks":[]}],"_type":"block"},{"markDefs":[],"children":[{"marks":["strong"],"text":"Dark Therapy for Depression","_key":"e1c47995de9a0","_type":"span"}],"_type":"block","style":"normal","_key":"8e7e003f8d09"},{"children":[{"_type":"span","marks":["strong"],"text":"KN","_key":"1a8bcf789c6c0"},{"_type":"span","marks":[],"text":": Blue light blockers have a big effect in mania and rapid cycling, and for sleep they deepen sleep quality and turn night owls into morning people. But can they help depression? We know from animal studies and epidemiologic studies that blue light causes depression, but when it comes to clinical studies using blue light blockers to treat depression the results are mixed. In that CBT-insomnia study, they did improve depressive symptoms, but those patients had clinical insomnia, not clinical depression.","_key":"1a8bcf789c6c1"},{"text":"10","_key":"a07fecd7c3f5","_type":"span","marks":["superscript"]},{"marks":[],"text":" Beyond that, we have only 2 controlled trials, 1 positive, 1 negative. The positive one was small (n = 27) and centered on postpartum depression, where nocturnal awakening is the norm. Women who used blue-light blockers and low-blue light bulbs had greater improvements than those who used placebo glasses and bulbs.","_key":"6e47b195828e","_type":"span"},{"_key":"b361669caef5","_type":"span","marks":["superscript"],"text":"13"},{"_type":"span","marks":[],"text":" The negative study was also small (n = 20) and included depressed patients with insomnia. The investigators suspected that the glasses might not have worked because the patients found them uncomfortable and did not wear them as much as they should.","_key":"28351afde38b"},{"text":"14","_key":"489c274fec81","_type":"span","marks":["superscript"]}],"_type":"block","style":"normal","_key":"d00277c9dd9f","markDefs":[]},{"_type":"block","style":"normal","_key":"95648ec7ee55","markDefs":[],"children":[{"marks":["strong"],"text":"Warnings","_key":"8ef4c38d11c10","_type":"span"}]},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"CA","_key":"e8037cb641160"},{"_type":"span","marks":[],"text":": When worn at night, blue light filters have beneficial, biological effects, but can they have side effects? Nothing major showed up in the studies. Possibly headaches, and there are reports of depression in some patients. This usually improves by putting the glasses on later, say, 7 PM or 8 PM instead of 6 PM. Although you can see pretty clearly through the glasses, color vision is distorted so we don’t recommend them while driving.","_key":"e8037cb641161"}],"_type":"block","style":"normal","_key":"0a03b0a2d077"},{"children":[{"_type":"span","marks":["strong"],"text":"KELLIE NEWSOME","_key":"8eabe01ecb250"},{"_type":"span","marks":[],"text":": We have links to recommended brands of blue-light blockers in the text to this podcast. 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Newsome, PMH-NP","_key":"2b7ceabebc6822"},{"marks":["em"],"text":", is the cohost of the","_key":"2b7ceabebc6823","_type":"span"},{"_type":"span","marks":[],"text":" ","_key":"2b7ceabebc6824"},{"_type":"span","marks":["em"],"text":"Carlat Psychiatry Podcast","_key":"2b7ceabebc6825"},{"_type":"span","marks":[],"text":" ","_key":"2b7ceabebc6826"},{"_type":"span","marks":["em"],"text":"and is also a practicing psychiatric mental health nurse practitioner in Winston Salem, NC, at the Mood Treatment Center. Raised in Tasmania, Australia, Kellie moved to the United States in 1998.","_key":"2b7ceabebc6827"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"References","_key":"25ac8fc73e8e0"}],"_type":"block","style":"normal","_key":"00d1c1880f33"},{"_type":"block","style":"normal","_key":"fa2d733e1e09","markDefs":[{"_key":"9ffb957f4ad0","_type":"link","href":"https://www.ncbi.nlm.nih.gov/pubmed/23926261"}],"children":[{"marks":[],"text":"1. Bedrosian TA, Vaughn CA, Galan A, et al. ","_key":"080d896164030","_type":"span"},{"_type":"span","marks":["9ffb957f4ad0"],"text":"Nocturnal light exposure impairs affective responses in a wavelength-dependent manner.","_key":"080d896164031"},{"text":" ","_key":"080d896164032","_type":"span","marks":[]},{"_type":"span","marks":["em"],"text":"J Neurosci. ","_key":"080d896164033"},{"_type":"span","marks":[],"text":"2013;33(32):13081-13087.","_key":"080d896164034"}]},{"children":[{"_type":"span","marks":[],"text":"2. Henriksen TE, Skrede S, Fasmer OB, et al. ","_key":"f690684f295a0"},{"text":"Blue-blocking glasses as additive treatment for mania: a randomized placebo-controlled trial.","_key":"f690684f295a1","_type":"span","marks":["45124289dcea"]},{"_type":"span","marks":[],"text":" ","_key":"f690684f295a2"},{"_type":"span","marks":["em"],"text":"Bipolar Disord","_key":"f690684f295a3"},{"_type":"span","marks":[],"text":". 2016;18(3):221-232.","_key":"f690684f295a4"}],"_type":"block","style":"normal","_key":"b97351169646","markDefs":[{"_type":"link","href":"https://www.ncbi.nlm.nih.gov/pubmed/27226262","_key":"45124289dcea"}]},{"markDefs":[{"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/32252567/","_key":"3884d6ee42b8"}],"children":[{"text":"3. Wang RR, Hao Y, Guo H, et al. ","_key":"9bd0c1b6373b0","_type":"span","marks":[]},{"text":"Lunar cycle and psychiatric hospital admissions for schizophrenia: new findings from Henan province, China.","_key":"9bd0c1b6373b1","_type":"span","marks":["3884d6ee42b8"]},{"_type":"span","marks":[],"text":" ","_key":"9bd0c1b6373b2"},{"_key":"9bd0c1b6373b3","_type":"span","marks":["em"],"text":"Chronobiol Int"},{"marks":[],"text":". 2020;37(3):438-449.","_key":"9bd0c1b6373b4","_type":"span"}],"_type":"block","style":"normal","_key":"0998fad1e801"},{"_type":"block","style":"normal","_key":"5cb7b6d5d358","markDefs":[{"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/15713707/","_key":"56e546bfed16"}],"children":[{"marks":[],"text":"4. Kayumov L, Casper RF, Hawa RJ, et al. ","_key":"5c883b154b8e0","_type":"span"},{"_type":"span","marks":["56e546bfed16"],"text":"Blocking low-wavelength light prevents nocturnal melatonin suppression with no adverse effect on performance during simulated shift work.","_key":"5c883b154b8e1"},{"_type":"span","marks":[],"text":" ","_key":"5c883b154b8e2"},{"_key":"5c883b154b8e3","_type":"span","marks":["em"],"text":"J Clin Endocrinol Metab"},{"text":". 2005;90(5):2755-2761.","_key":"5c883b154b8e4","_type":"span","marks":[]}]},{"_key":"ace75fc73a52","markDefs":[{"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/32474993/","_key":"661b6401c265"}],"children":[{"_key":"e625229b6ed90","_type":"span","marks":[],"text":"5. Quested DJ, Gibson JC, Sharpley AL, et al. Melatonin In Acute Mania Investigation (MIAMI-UK). "},{"marks":["661b6401c265"],"text":"A randomized controlled trial of add-on melatonin in bipolar disorder.","_key":"e625229b6ed91","_type":"span"},{"_type":"span","marks":[],"text":" ","_key":"e625229b6ed92"},{"_type":"span","marks":["em"],"text":"Bipolar Disord","_key":"e625229b6ed93"},{"_type":"span","marks":[],"text":". 2021;23(2):176-185.","_key":"e625229b6ed94"}],"_type":"block","style":"normal"},{"_key":"a2db7ccafcdf","markDefs":[{"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/7512910/","_key":"d792a216f0c0"}],"children":[{"_type":"span","marks":[],"text":"6. Barbato G, Barker C, Bender C, et al. ","_key":"94ff1ad30bae0"},{"_type":"span","marks":["d792a216f0c0"],"text":"Extended sleep in humans in 14 hour nights (LD 10:14): relationship between REM density and spontaneous awakening.","_key":"94ff1ad30bae1"},{"_key":"94ff1ad30bae2","_type":"span","marks":[],"text":" "},{"_key":"94ff1ad30bae3","_type":"span","marks":["em"],"text":"Electroencephalogr Clin Neurophysiol"},{"_type":"span","marks":[],"text":". 1994;90(4):291-297.","_key":"94ff1ad30bae4"}],"_type":"block","style":"normal"},{"_key":"f3ff2e13b6ea","markDefs":[{"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/9611672/","_key":"a8d7ad388575"}],"children":[{"text":"7. Wehr TA, Turner EH, Shimada JM, et al. ","_key":"f8285e4742170","_type":"span","marks":[]},{"_type":"span","marks":["a8d7ad388575"],"text":"Treatment of rapidly cycling bipolar patient by using extended bed rest and darkness to stabilize the timing and duration of sleep.","_key":"f8285e4742171"},{"_type":"span","marks":[],"text":" ","_key":"f8285e4742172"},{"_type":"span","marks":["em"],"text":"Biol Psychiatry","_key":"f8285e4742173"},{"marks":[],"text":". 1998;43(11):822-828.","_key":"f8285e4742174","_type":"span"}],"_type":"block","style":"normal"},{"_key":"c9d938860932","markDefs":[{"href":"https://pubmed.ncbi.nlm.nih.gov/17637502/","_key":"b6de4ee3a9d5","_type":"link"}],"children":[{"marks":[],"text":"8. Phelps J. ","_key":"15cd6439011c0","_type":"span"},{"_type":"span","marks":["b6de4ee3a9d5"],"text":"Dark therapy for bipolar disorder using amber lenses for blue light blockade.","_key":"15cd6439011c1"},{"_type":"span","marks":[],"text":" ","_key":"15cd6439011c2"},{"_key":"15cd6439011c3","_type":"span","marks":["em"],"text":"Med Hypotheses. "},{"_type":"span","marks":[],"text":"2008;70(2):224-229.","_key":"15cd6439011c4"}],"_type":"block","style":"normal"},{"_key":"d5589aa2a9de","markDefs":[{"_key":"6b047725a205","_type":"link","href":"https://www.ncbi.nlm.nih.gov/pubmed/28992236"}],"children":[{"_type":"span","marks":[],"text":"9. Obayashi K, Saeki K, Kurumatani N. ","_key":"5b92afa3ece60"},{"_key":"5b92afa3ece61","_type":"span","marks":["6b047725a205"],"text":"Bedroom light exposure at night and the incidence of depressive symptoms: a longitudinal study of the heijo-kyo cohort."},{"_key":"5b92afa3ece62","_type":"span","marks":[],"text":" "},{"_type":"span","marks":["em"],"text":"Am J Epidemiol","_key":"5b92afa3ece63"},{"_key":"5b92afa3ece64","_type":"span","marks":[],"text":". 2018;187(3):427-434."}],"_type":"block","style":"normal"},{"_key":"498c3a744878","markDefs":[{"_key":"8cd871f52d20","_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/31752544/"}],"children":[{"_type":"span","marks":[],"text":"10. Janků K, Šmotek M, Fárková E, Kopřivová J. ","_key":"c142486ddec20"},{"_type":"span","marks":["8cd871f52d20"],"text":"Block the light and sleep well: Evening blue light filtration as a part of cognitive behavioral therapy for insomnia","_key":"c142486ddec21"},{"_type":"span","marks":[],"text":". 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Four strategies to manage this uncertainty include gathering comprehensive data, involving patients and families in decision-making, initiating psychotherapy (including digital therapeutics), and comparing treatment risks. Gathering data involves using tools like the \"MoodCheck\" questionnaire. Patient education and reliable internet resources are crucial. Digital therapeutics offer promising alternatives to traditional therapy, with new CPT codes proposed for reimbursement. 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With these symptoms, bipolar mixed states overlap almost completely with those of ","_key":"4e5ff86c7daf0"},{"_key":"67ebf2a933fc","_type":"span","marks":["1ea498eb1a16"],"text":"posttraumatic stress disorder"},{"_key":"e2ed83948b3e","_type":"span","marks":[],"text":" (PTSD) with depression, generalized anxiety disorder (GAD) with depression, attention deficit disorder (ADD) with depression, and "},{"text":"borderline personality disorder","_key":"329ff50803c8","_type":"span","marks":["6364a9ec098f"]},{"_key":"2f62088f407c","_type":"span","marks":[],"text":"."}]},{"_type":"block","style":"normal","_key":"a579010d1481","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"7a378520683c0"}]},{"_type":"block","style":"normal","_key":"409bec3037da","markDefs":[],"children":[{"_type":"span","marks":[],"text":"This essay presents 4 means of coping with the diagnostic uncertainty that results from this overlap.","_key":"f35dc399e7a80"}]},{"markDefs":[],"children":[{"_key":"f8b63e5eab280","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal","_key":"08be638e487c"},{"_type":"block","style":"normal","_key":"49aed91bd7ef","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"1. 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No diagnosis should be proffered until they are obtained and evaluated.","_key":"06da9a469a8d0","_type":"span"}]},{"_key":"7e8f74f43677","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"a35b7b0349e60"}],"_type":"block","style":"normal"},{"style":"normal","_key":"424ec05c9df6","markDefs":[{"blank":true,"_type":"link","href":"https://www.psychiatrictimes.com/view/efficient-assessment-20-questions-about-bipolarity-moodcheck","_key":"1d4afd973797"}],"children":[{"_type":"span","marks":[],"text":"But the sheer volume of information one is expected to gather in an initial interview can interfere with establishing trust and rapport through open-ended questions and accurate reflective listening. Using questionnaires to gather some of this information is efficient but can be cumbersome: how much can you ask a patient to divulge before meeting you in person? For a short questionnaire designed to capture mood symptoms ","_key":"3d648a40293e0"},{"marks":["em"],"text":"and","_key":"3d648a40293e1","_type":"span"},{"_type":"span","marks":[],"text":" family history, age of onset, illness course, and response to antidepressants, consider “MoodCheck”, described in ","_key":"3d648a40293e2"},{"_type":"span","marks":["em"],"text":"Psychiatric Times","_key":"3d648a40293e3"},{"_key":"3d648a40293e4","_type":"span","marks":[],"text":" in "},{"_type":"span","marks":["1d4afd973797"],"text":"2017","_key":"3d648a40293e5"},{"_type":"span","marks":[],"text":" and available for direct download (no profit or industry connections).","_key":"3d648a40293e6"},{"text":"3","_key":"fb27cc7d34d6","_type":"span","marks":["superscript"]}],"_type":"block"},{"style":"normal","_key":"c6bfafb49464","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"24f6d130b6200"}],"_type":"block"},{"_key":"e5f882a4b647","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"2. 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How much stigma is attached to the word bipolar, in the patient’s mind, and their family’s, and their community?","_key":"ee2c5548804d0"}],"_type":"block","style":"normal","_key":"9c1deae87048","markDefs":[]},{"_type":"block","style":"normal","_key":"04848dcbb3b0","markDefs":[],"children":[{"_key":"d44a0069a4170","_type":"span","marks":[],"text":""}]},{"_key":"08d4d5af8095","markDefs":[],"children":[{"text":"With these insights in hand or in development, a good clinician helps the patient (and perhaps family) understand the diagnostic challenge of mixed states. One might say “There are a couple of ways to explain your symptoms. No single diagnosis is obvious. We have to consider several” (enumerating those most likely, including bipolar without mania). Another variation: “You do not have bipolar disorder, but you do not have plain depression either. You may be somewhere in between.”","_key":"ffb23894da5a0","_type":"span","marks":[]}],"_type":"block","style":"normal"},{"_key":"3f9b3c10f471","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"e364a4bc28500"}],"_type":"block","style":"normal"},{"style":"normal","_key":"b9ae5a9e4f8c","markDefs":[],"children":[{"_type":"span","marks":[],"text":"When time is limited, especially in an initial interview, it is almost impossible to be this deliberate explaining a complex differential. But many patients, if they leave with limited information, will turn to the internet. Unguided searching can easily lead to misimpressions. You could create your own website, or a handout of recommended sites to direct your patients’ searches. For that list, consider a site built recently for patients with depression that emphasizes all the themes in the essay you are reading now (no profit, no advertising).","_key":"bd5f7bd5e02f0"},{"_type":"span","marks":["superscript"],"text":"4","_key":"16497d1efc3e"}],"_type":"block"},{"style":"normal","_key":"3c1600dc27b5","markDefs":[],"children":[{"_key":"01062a9426d70","_type":"span","marks":[],"text":""}],"_type":"block"},{"style":"normal","_key":"147362824611","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"3. 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Psychotherapies have lower risks than medications, even if targeting the “wrong” diagnosis; indeed, several are likely to help even when misdirected.","_key":"1ac8ffc40373","_type":"span"}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"a8990d1b4beb0"}],"_type":"block","style":"normal","_key":"1a57a9fa4813"},{"_type":"block","style":"normal","_key":"9c7e13d94e00","markDefs":[],"children":[{"_type":"span","marks":[],"text":"In the face of diagnostic uncertainty, you can offer or refer the patient to a psychotherapy specific for the most likely diagnosis, or therapy likely to benefit any of several diagnostic possibilities. For example, some therapies are PTSD-specific, focusing on trauma, while basic cognitive-behavioral therapy (CBT) may still be of benefit in PTSD through components such as stress management and mindfulness skills. Similarly, CBT is likely to help a patient whose depression is mixed, or even bipolar II depression. A meta-analysis of 409 trials found CBT equally effective as medications for depression in the short term, and better in the long term.","_key":"627ba31e9a3a0"},{"_type":"span","marks":["superscript"],"text":"5","_key":"d38313e2c465"}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"aa3bb1c3ab200"}],"_type":"block","style":"normal","_key":"f9396c3b2c78"},{"markDefs":[],"children":[{"text":"Unfortunately, unless you have a solid referral network, it can be difficult to confidently refer patients for psychotherapy. The best local therapists are often not routinely taking new patients. For online therapy, some websites allow a patient to choose a particular kind of therapy, but you cannot control the quality.","_key":"69922eaa370b0","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"4c21870797ce"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"46b370ff497e0"}],"_type":"block","style":"normal","_key":"f8599a3ed871"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Digital therapeutics (DTX) include websites and apps that provide a kind of psychotherapy. Web-based versions of CBT have been shown to be nearly as effective as a live therapist, particularly if guided with some minimal support.","_key":"ae7378618d4e0"},{"_type":"span","marks":["superscript"],"text":"6","_key":"af6584f9cf3c"},{"_key":"b5daf72142f6","_type":"span","marks":[],"text":" Online therapies for PTSD also have shown efficacy, although patients are more likely to drop out if the intervention focuses on stabilization (as do the majority of such programs) when they are looking for trauma-focused work."},{"_type":"span","marks":["superscript"],"text":"7","_key":"57dc2804b8da"}],"_type":"block","style":"normal","_key":"c3ad4a1af5f9"},{"children":[{"_type":"span","marks":[],"text":"","_key":"c750da621e810"}],"_type":"block","style":"normal","_key":"e6ed0303cf28","markDefs":[]},{"markDefs":[],"children":[{"_key":"6e1078fed0820","_type":"span","marks":[],"text":"Some of the best studied versions of online CBT rely on patient motivation to work through the modules."},{"_type":"span","marks":["superscript"],"text":"8","_key":"7a43e9df9599"},{"_type":"span","marks":[],"text":" Completion rates have been as low as 10% in some of these studies.","_key":"0d6304d98299"},{"text":"9","_key":"0597a5194280","_type":"span","marks":["superscript"]},{"_type":"span","marks":[],"text":" By contrast, newer DTX programs “push” adherence with programmed messages and limited text-based support. With these, 1 industry-sponsored study demonstrated almost 90% adherence after 12 of 16 sessions.","_key":"fe48900dd3f1"},{"text":"10","_key":"e95681bcae79","_type":"span","marks":["superscript"]}],"_type":"block","style":"normal","_key":"c2840482743d"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"ee4b5841248b0"}],"_type":"block","style":"normal","_key":"07943f40613a"},{"markDefs":[],"children":[{"text":"In that industry-sponsored study, the absolute difference in the primary outcome measure (MADRS) vs an active control condition was small. But all patients were already on an antidepressant and the control was a very plausible version of the treatment app, perhaps limiting improvement and separation. Data from further research will be of great interest. In the meantime, it appears that the push technology represents a major advance vs older DTXs.","_key":"beaeefab38d60","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"a8cd0a74de9d"},{"children":[{"_type":"span","marks":[],"text":"","_key":"679b26ba5e450"}],"_type":"block","style":"normal","_key":"7152a1da38ba","markDefs":[]},{"style":"normal","_key":"c496c3cbbf2f","markDefs":[],"children":[{"_type":"span","marks":[],"text":"As a final reason to more deeply consider adding DTX to your toolkit, note that Medicare and Medicaid Services have proposed new CPT codes that would pay for prescribing and managing these tools. (In an important twist, only “FDA-approved” programs would be allowed, thus excluding several existing programs that have not sought such approval). Code GMBT1 would allow clinicians to bill for giving DTX to patients and teaching them how to use it. The idea is to make DTX rather like giving a vaccine. Code GMBT2 covers the first 20 minutes of “monthly management services,” such as reviewing the data from the DTX device.","_key":"8f248968726f0"},{"text":"11","_key":"de7dab8a8bfb","_type":"span","marks":["superscript"]}],"_type":"block"},{"_key":"3305fa1be214","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"5fa46fc4153c0"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"1a9e9ab3e57a","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"4. Compare Treatment Risks","_key":"2fb32e6222360"}]},{"children":[{"_key":"709ecdf704770","_type":"span","marks":[],"text":"If beginning with a medication treatment rather than a psychotherapy, a fourth means of coping with diagnostic uncertainty is to help the patient compare the risks of treatment options associated with possible diagnoses. This approach is detailed in Part 3 of this series."}],"_type":"block","style":"normal","_key":"0e1e0631dfde","markDefs":[]},{"_type":"block","style":"normal","_key":"340b73a3e070","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"50f0439333cd0"}]},{"style":"normal","_key":"ec6f1eb38e1b","markDefs":[],"children":[{"_key":"6029913f51c40","_type":"span","marks":["strong"],"text":"Concluding Thoughts"}],"_type":"block"},{"children":[{"_type":"span","marks":[],"text":"Because of overlapping symptoms, distinguishing mixed states from other common presentations of depression can be nearly impossible. This essay describes 4 means of coping with that uncertainty, including respective clinical tools: ","_key":"e692eaca9ba70"},{"_type":"span","marks":["em"],"text":"gathering data","_key":"e692eaca9ba71"},{"marks":[],"text":" using a broad but brief questionnaire; ","_key":"e692eaca9ba72","_type":"span"},{"text":"patient education","_key":"e692eaca9ba73","_type":"span","marks":["em"]},{"_key":"e692eaca9ba74","_type":"span","marks":[],"text":", augmented with reliable internet sources; starting with a "},{"_key":"e692eaca9ba75","_type":"span","marks":["em"],"text":"psychotherapy"},{"_type":"span","marks":[],"text":", including DTX; and patient education ","_key":"e692eaca9ba76"},{"_type":"span","marks":["em"],"text":"comparing treatment risks","_key":"e692eaca9ba77"},{"_type":"span","marks":[],"text":".","_key":"e692eaca9ba78"}],"_type":"block","style":"normal","_key":"bceb3730b6f6","markDefs":[]},{"markDefs":[],"children":[{"_key":"56939e5608990","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal","_key":"52e6fed7438a"},{"children":[{"_type":"span","marks":["strong"],"text":"Dr Phelps","_key":"ec89bee9541f0"},{"_type":"span","marks":[],"text":" ","_key":"ec89bee9541f1"},{"marks":["em"],"text":"is retiring from 30 years of treating complex mood disorders, and recently founded another website, DepressionEducation.org. He is the bipolar disorder section editor for ","_key":"ec89bee9541f2","_type":"span"},{"text":"Psychiatric Times®","_key":"ec89bee9541f3","_type":"span","marks":[]},{"_type":"span","marks":["em"],"text":" and the author of","_key":"ec89bee9541f4"},{"_type":"span","marks":[],"text":" ","_key":"ec89bee9541f5"},{"text":"A Spectrum Approach to Mood Disorders","_key":"ec89bee9541f6","_type":"span","marks":["ca2683fb96a4"]},{"_type":"span","marks":["em"],"text":" for clinicians and","_key":"ec89bee9541f7"},{"text":" ","_key":"ec89bee9541f8","_type":"span","marks":[]},{"_type":"span","marks":["c778ff5bea03"],"text":"Bipolar, Not So Much","_key":"ec89bee9541f9"},{"_type":"span","marks":[],"text":" ","_key":"ec89bee9541f10"},{"_type":"span","marks":["em"],"text":"for patients and their families","_key":"ec89bee9541f11"},{"marks":[],"text":".","_key":"ec89bee9541f12","_type":"span"}],"_type":"block","style":"normal","_key":"7805dc0c6f64","markDefs":[{"blank":true,"_type":"link","href":"https://wwnorton.com/books/A-Spectrum-Approach-to-Mood-Disorders/","_key":"ca2683fb96a4"},{"href":"https://wwnorton.com/books/Bipolar-Not-So-Much/","_key":"c778ff5bea03","blank":true,"_type":"link"}]},{"_key":"28abf4f6a063","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"2f6e7f2155cb0"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"References","_key":"67ddc72426800"}],"_type":"block","style":"normal","_key":"bf014d87bba7"},{"children":[{"_key":"7a240a9e93da0","_type":"span","marks":[],"text":"1. Mitchell PB, Goodwin GM, Johnson GF, Hirschfeld RM. "},{"_key":"7a240a9e93da1","_type":"span","marks":["c0d37f0aac4a"],"text":"Diagnostic guidelines for bipolar depression: a probabilistic approach."},{"_key":"bda32fe24155","_type":"span","marks":[],"text":" "},{"_type":"span","marks":["em"],"text":"Bipolar Disord","_key":"7a240a9e93da2"},{"_type":"span","marks":[],"text":". 2008;10(1 pt 2):144-152.","_key":"7a240a9e93da3"}],"_type":"block","style":"normal","_key":"3ba195b3cb36","markDefs":[{"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/18199233/","_key":"c0d37f0aac4a","blank":true}]},{"markDefs":[{"blank":true,"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/18199236/","_key":"b0fb3d72396b"}],"children":[{"marks":[],"text":"2. Phelps J, Angst J, Katzow J, Sadler J. ","_key":"76925323d1ba0","_type":"span"},{"_key":"76925323d1ba1","_type":"span","marks":["b0fb3d72396b"],"text":"Validity and utility of bipolar spectrum models."},{"_type":"span","marks":["em"],"text":" Bipolar Disord.","_key":"76925323d1ba2"},{"_type":"span","marks":[],"text":" 2008;10(1 pt 2):179-193.","_key":"76925323d1ba3"}],"_type":"block","style":"normal","_key":"f63d8051cf0a"},{"_key":"6f1c01ea31cc","markDefs":[{"blank":true,"_type":"link","href":"https://depressioneducation.org/depression-section-page-1/questionnaire-moodcheck/","_key":"fdcdc08bbfc0"}],"children":[{"_type":"span","marks":[],"text":"3. MoodCheck. Depression Education. Accessed November 7, 2024. ","_key":"e3511d2120b90"},{"text":"https://depressioneducation.org/depression-section-page-1/questionnaire-moodcheck/","_key":"e3511d2120b91","_type":"span","marks":["fdcdc08bbfc0"]}],"_type":"block","style":"normal"},{"_key":"e3804abe06c5","markDefs":[{"blank":true,"_type":"link","href":"https://depressioneducation.org/","_key":"8c2129845eb1"}],"children":[{"marks":[],"text":"4. Depression Education. Accessed November 7, 2024. ","_key":"107d260e128d0","_type":"span"},{"_type":"span","marks":["8c2129845eb1"],"text":"https://depressioneducation.org/","_key":"107d260e128d1"}],"_type":"block","style":"normal"},{"markDefs":[{"href":"https://pubmed.ncbi.nlm.nih.gov/36640411/","_key":"e9e8fd514891","blank":true,"_type":"link"}],"children":[{"_type":"span","marks":[],"text":"5. Cuijpers P, Miguel C, Harrer M, et al. ","_key":"a6931add4d130"},{"_type":"span","marks":["e9e8fd514891"],"text":"Cognitive behavior therapy vs. control conditions, other psychotherapies, pharmacotherapies and combined treatment for depression: a comprehensive meta‐analysis including 409 trials with 52,702 patients.","_key":"a6931add4d131"},{"_type":"span","marks":[],"text":" ","_key":"c10fb1005472"},{"_type":"span","marks":["em"],"text":"World Psychiatry","_key":"a6931add4d132"},{"marks":[],"text":". 2023;22(1):105-115.","_key":"a6931add4d133","_type":"span"}],"_type":"block","style":"normal","_key":"1fd7d4367ef2"},{"markDefs":[{"_type":"link","href":"https://pubmed.ncbi.nlm.nih.gov/33471111/","_key":"d9fde6da4e47","blank":true}],"children":[{"_type":"span","marks":[],"text":"6. Karyotaki E, Efthimiou O, Miguel C, et al. 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Comprehensive data collection, including family history and antidepressant reactions, aids in distinguishing bipolar depression.\n\n• Digital therapeutics and psychotherapy offer effective alternatives to medication, with new CPT codes proposed for reimbursement.\n\n• Patient involvement and education, supported by reliable internet resources, are crucial in managing diagnostic uncertainty.","_type":"article","summary":"Here are 4 means of coping with the diagnostic uncertainty of bipolar mixed 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The study, involving 1283 patients aged 12 to 21, demonstrated significant improvements, with 59.4% of adolescents achieving remission. The therapy's effectiveness increased with longer treatment courses, and it was well-tolerated with minimal adverse effects. NeuroStar is the only FDA-cleared TMS device for adolescents aged 15 and older, offering a valuable non-drug treatment option for this population.","published":"2024-11-14T17:30:56.510Z","audioUrl":"https://s3.us-east-1.amazonaws.com/ai-generated-audios/www.psychiatrictimes.com/80fe38da-e61d-48de-9682-3f13902fb601_1731603565566.51b8b2be-202f-4d51-9e46-aaecb27d1081.mp3","contentCategory":{"_createdAt":"2020-02-06T09:15:47Z","_rev":"snQqhhB4O8T5bi1viURsgs","_type":"contentCategory","name":"Articles","_id":"8bdaa7fc-960a-4b57-b076-75fdce3741bb","_updatedAt":"2020-02-25T09:35:56Z"},"articleType":"News","_updatedAt":"2024-11-14T16:59:36Z","summary":"According to new data, NeuroStar Advanced TMS helped nearly 60% of adolescents with major depressive disorder. 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Investigators sought to determine the outcomes of adolescents and young adults aged 12 to 21 years with MDD and anxiety who were treated with TMS in community settings.","_key":"6b4ff6c9ccc20","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"1","_key":"504f02ba7aa1"}],"_type":"block"},{"_type":"block","style":"normal","_key":"c0796d156425","markDefs":[],"children":[{"text":"","_key":"9b61e6c990980","_type":"span","marks":[]}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Data were extracted from a treatment registry of 1283 patients with MDD; 682 patients were aged 12 to 19 years, and 601 were aged 20 to 21 years. This is the largest sample to date of adolescents and young adults with MDD. Primary outcome measures were the Patient Health Questionnaire-9 (PHQ–9) and Generalized Anxiety Disorder-7 (GAD–7).","_key":"ee667ad5886d0"},{"text":"2","_key":"c2763010d72d","_type":"span","marks":["superscript"]},{"_type":"span","marks":[],"text":" The analyses examined outcomes from patients who completed 20 or more sessions and an intent-to-treat sample. In the completer sample (N=1169), results show that 59.4% of patients aged 12 to 19 and 36.4% of patients aged 20 to 21 met the PHQ-9 response and remission criteria, respectively. Investigators observed marked dose-response effects and antidepressant effectiveness improved with longer treatment courses (","_key":"0858f8a29cca"},{"_type":"span","marks":["em"],"text":"P","_key":"ee667ad5886d1"},{"_type":"span","marks":[],"text":" \u003c .0001). The greatest symptom reduction was seen over the first 10 sessions, with no plateau before treatment termination. The adolescent and young adult subgroup data did not differ in treatment effects.","_key":"ee667ad5886d2"}],"_type":"block","style":"normal","_key":"d353fb821675"},{"_key":"20cdbc51c957","markDefs":[],"children":[{"marks":[],"text":"","_key":"91119b560b000","_type":"span"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"To better understand this data, ","_key":"31d39c37c9fe0"},{"_type":"span","marks":["em"],"text":"Psychiatric Times","_key":"31d39c37c9fe1"},{"_type":"span","marks":[],"text":" sat down with Melissa Fickey, MD, a board-certified psychiatrist who specializes in child, adolescent, and adult psychiatry.","_key":"31d39c37c9fe2"}],"_type":"block","style":"normal","_key":"afa0bef10d10"},{"_key":"5b09d65b01e9","markDefs":[],"children":[{"marks":[],"text":"","_key":"0f79286933220","_type":"span"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"6a43c92a74b9","markDefs":[],"children":[{"_type":"span","marks":["strong","em"],"text":"Psychiatric Times","_key":"9a0d9a5b2a3e0"},{"_type":"span","marks":["strong"],"text":": Tell us a little about that data shared at the AACAP annual meeting. What is the most important takeaway from this data for practicing mental health clinicians?","_key":"9a0d9a5b2a3e1"}]},{"markDefs":[],"children":[{"text":"Melissa Fickey, MD:","_key":"63aea03040740","_type":"span","marks":["strong"]},{"_type":"span","marks":[],"text":" The data presented at AACAP highlights a breakthrough for teens and young adults struggling with depression and, in some cases, anxiety. This study was the most extensive of its kind, examining over 1200 young people aged 12 to 21 years old who received treatment with NeuroStar Advanced Therapy’s TMS. The results were very encouraging and showed more than 70% of those treated experienced meaningful improvements (or a 6 point or more change in their PHQ-9 score).","_key":"63aea03040741"}],"_type":"block","style":"normal","_key":"288ea6f01d78"},{"_key":"aa8057b97788","markDefs":[],"children":[{"_key":"c93602c989d70","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal"},{"_key":"75b4e44cf8b3","markDefs":[],"children":[{"_type":"span","marks":[],"text":"The positive results from this study reinforce the FDA clearance, as NeuroStar is the only FDA-cleared TMS device for treating adolescents with MDD aged 15 and older. Prior data also show a 78% response rate and 48% remission rates in teens and ultimately provide compelling evidence supporting TMS as a highly effective treatment for adolescents with MDD.","_key":"34c1ca2a82990"}],"_type":"block","style":"normal"},{"style":"normal","_key":"f6fa6b776e2d","markDefs":[],"children":[{"marks":[],"text":"","_key":"5114760343490","_type":"span"}],"_type":"block"},{"style":"normal","_key":"1b99b514171f","markDefs":[],"children":[{"_type":"span","marks":["strong","em"],"text":"PT","_key":"3c46129435150"},{"_type":"span","marks":["strong"],"text":": Do you think this data will help patients and families considering TMS feel more comfortable?","_key":"3c46129435151"}],"_type":"block"},{"_key":"18c83b0c8385","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Fickey:","_key":"60295a859f8c0"},{"_type":"span","marks":[],"text":" This data can provide significant confidence to patients and their families who might be apprehensive about beginning treatment with TMS. As mentioned, these are the largest study results of its kind, and they reinforce the safety and effectiveness the FDA reviewed when deciding NeuroStar is a first-line add-on option for adolescents with MDD age 15 and up. Not only did most participants experience meaningful improvements in both depression and anxiety, but adverse effects were minimal. Additionally, the data show treatment made an impact after only a few sessions and results improved for those who completed a full treatment course.","_key":"60295a859f8c1"}],"_type":"block","style":"normal"},{"_key":"c6e25bab60df","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"ddf527abee290"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"marks":["strong","em"],"text":"PT","_key":"8b5514a4753b0","_type":"span"},{"_type":"span","marks":["strong"],"text":": Treatment with TMS resulted in marked improvement in both depressive symptoms and anxiety in adolescents and young adults. There are limited approved treatment options in this age category. At what point do you determine it is time to try TMS?","_key":"8b5514a4753b1"}],"_type":"block","style":"normal","_key":"f63aaba8ed99"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Fickey: ","_key":"8a176487dd8c0"},{"_key":"8a176487dd8c1","_type":"span","marks":[],"text":"NeuroStar is currently the only TMS therapy that is approved as a first-line adjunct treatment for adolescents—so it can be a first-line option for adolescents aged 15 and up in conjunction with other modalities, like antidepressant medications or talk therapy. It can also be used if a patient has tried other options but is not seeing a large impact on their mental health. MDD is a substantial public health challenge impacting at least 4.3 million adolescents annually in the United States, but despite current options, symptoms do not improve in approximately 30% of adolescents who opt for traditional antidepressants, according to independent NIH studies."},{"_type":"span","marks":["superscript"],"text":"3","_key":"32f3f8af5811"}],"_type":"block","style":"normal","_key":"a978b5a1f0c0"},{"_type":"block","style":"normal","_key":"7ed4de60cf44","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"d91c58b666100"}]},{"style":"normal","_key":"c51261adbc58","markDefs":[],"children":[{"marks":[],"text":"TMS offers a new pathway for relief without the systemic adverse effects typical of antidepressant medications, which can be a huge help to younger patients and their families. The data presented at AACAP show us that the earlier we introduce TMS in persistent cases, the better the outcomes can be.","_key":"df6576ed24ad0","_type":"span"}],"_type":"block"},{"children":[{"_type":"span","marks":[],"text":"","_key":"820f870040390"}],"_type":"block","style":"normal","_key":"5b5b8778c684","markDefs":[]},{"children":[{"_type":"span","marks":["strong","em"],"text":"PT","_key":"0c330aba316c0"},{"_type":"span","marks":["strong"],"text":": NeuroStar is the only FDA-cleared TMS device to treat adolescents aged 15 and older as a first-line adjunct treatment. You are a diamond provider for NeuroStar TMS. Do you have any recommendations for mental health clinicians who might be considering utilizing TMS in their own practices?","_key":"0c330aba316c1"}],"_type":"block","style":"normal","_key":"c4b6cebab0fb","markDefs":[]},{"markDefs":[],"children":[{"text":"Fickey: ","_key":"0e23920e28f50","_type":"span","marks":["strong"]},{"_type":"span","marks":[],"text":"NeuroStar, as the only FDA-cleared device for patients aged 15 and up, stands out as a nondrug option, making a real difference for young people. I have been practicing with NeuroStar for 6 years, and the results we have seen in my practice, and from the data, show remarkable improvements in both depression and anxiety—it is an opportunity to offer a solution that can genuinely change lives.","_key":"0e23920e28f51"}],"_type":"block","style":"normal","_key":"cce4a9708b22"},{"style":"normal","_key":"901dad6169b5","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"5519098a302a0"}],"_type":"block"},{"children":[{"_type":"span","marks":[],"text":"Beyond its clinical efficacy, integrating NeuroStar into practice offers several practical benefits that can further enhance patient care. One notable feature is the proprietary TrakStar Patient Data Management System, which streamlines patient data management. This system ensures a smooth experience for patients, from their initial consultation through treatment, fostering their engagement and commitment to the process. It also makes it easy on me and my staff to track a patient’s progress during the course of the treatment.","_key":"5de25489cf780"}],"_type":"block","style":"normal","_key":"9b09f553b4e1","markDefs":[]},{"children":[{"text":"","_key":"72068972af170","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"0f3701bd3f16","markDefs":[]},{"style":"normal","_key":"5b11d7625a5f","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Additionally, private and public insurance policies are increasingly covering it for adolescents and adult populations, reflecting a growing recognition of TMS as a valuable treatment option. This broader and rapidly increasing acceptance we have seen over the past few years—especially this year after the FDA clearance for adolescents—makes it that much easier to offer NeuroStar as an effective treatment for patients who are struggling.","_key":"17269170449a0"}],"_type":"block"},{"_type":"block","style":"normal","_key":"6093c8677bf1","markDefs":[],"children":[{"marks":[],"text":"","_key":"3a7f846c512e0","_type":"span"}]},{"style":"normal","_key":"5709fdc289f0","markDefs":[],"children":[{"_type":"span","marks":["strong","em"],"text":"PT","_key":"70fd59ba8bfa0"},{"_type":"span","marks":["strong"],"text":": Is there anything else you would like to share?","_key":"70fd59ba8bfa1"}],"_type":"block"},{"markDefs":[],"children":[{"marks":["strong"],"text":"Fickey: ","_key":"057fcd327ffa0","_type":"span"},{"_key":"057fcd327ffa1","_type":"span","marks":[],"text":"This study marks a pivotal moment in the treatment of depression and anxiety for adolescents and young adults. It is not just about the data—it is about opening new doors for those often underserved by traditional treatments. With such a large, real-world sample, I hope both patients and providers can see the true value of TMS—particularly how NeuroStar is transforming our approach to mental health in this age group. This research represents a beacon of progress, and I believe NeuroStar will change the landscape of adolescent mental health treatment for years to come."}],"_type":"block","style":"normal","_key":"32a44e093d06"},{"children":[{"marks":[],"text":"","_key":"3262be7e1e450","_type":"span"}],"_type":"block","style":"normal","_key":"e0b62e189f58","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":["strong","em"],"text":"PT","_key":"720e2c17fe900"},{"_type":"span","marks":["strong"],"text":": Thank you!","_key":"720e2c17fe901"}],"_type":"block","style":"normal","_key":"e405bcd8d637"},{"markDefs":[],"children":[{"marks":[],"text":"","_key":"f9d43cc9944d0","_type":"span"}],"_type":"block","style":"normal","_key":"d0aed13f0588"},{"markDefs":[],"children":[{"_key":"fcf6a268cb430","_type":"span","marks":["strong"],"text":"Dr Fickey"},{"_type":"span","marks":["em"],"text":" is a board-certified psychiatrist specializing in child, adolescent, and adult psychiatry and works as a forensic psychiatric consultant. She is also the founder of Embracing Life Wellness Center.","_key":"fcf6a268cb431"}],"_type":"block","style":"normal","_key":"9c6c5f82d7a5"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"864ece3643570"}],"_type":"block","style":"normal","_key":"01ecd5690649"},{"style":"normal","_key":"789bca0fc4aa","markDefs":[],"children":[{"text":"References","_key":"d974d6e2617c0","_type":"span","marks":["strong"]}],"_type":"block"},{"markDefs":[{"href":"https://ir.neuronetics.com/news-releases/news-release-details/neurostarr-oral-presentation-aacap-2024-highlights-largest-study","_key":"67dfee2e127f","blank":true,"_type":"link"}],"children":[{"_type":"span","marks":[],"text":"1. NeuroStar oral presentation at AACAP 2024 highlights largest study evaluating TMS efficacy in adolescents with depression. Neuronetics. News release. October 14, 2024. Accessed October 21, 2024. ","_key":"64e05aaf31bb0"},{"_type":"span","marks":["67dfee2e127f"],"text":"https://ir.neuronetics.com/news-releases/news-release-details/neurostarr-oral-presentation-aacap-2024-highlights-largest-study","_key":"64e05aaf31bb1"}],"_type":"block","style":"normal","_key":"4f7705a79162"},{"markDefs":[{"blank":true,"_type":"link","href":"https://www.jaacap.org/article/S0890-8567(24)01827-6/fulltext","_key":"f0601c0d66e4"}],"children":[{"_type":"span","marks":[],"text":"2. Croarkin PE, Aaronson ST, Carpenter LL, et al. ","_key":"0e8f810cd6330"},{"_key":"0e8f810cd6331","_type":"span","marks":["f0601c0d66e4"],"text":"A naturalistic study of transcranial magnetic stimulation treatment in adolescents and young adults with depression and anxiety."},{"_type":"span","marks":[],"text":" ","_key":"5b8212ddb890"},{"_type":"span","marks":["em"],"text":"J Am Acad Child Adolesc Psychiatry. 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","_key":"7d66ad7ef5c60"},{"_key":"7d66ad7ef5c61","_type":"span","marks":["a4faf87389ef"],"text":"Special populations: treatment-resistant depression in children and adolescents."},{"text":" ","_key":"1733e92d84a4","_type":"span","marks":[]},{"marks":["em"],"text":"Psychiatr Clin North Am","_key":"7d66ad7ef5c62","_type":"span"},{"_key":"7d66ad7ef5c63","_type":"span","marks":[],"text":". 2023;46(2):359-370."}],"_type":"block"}],"drugMentions":"{\"drug_mentions\": [\"NeuroStar\", \"antidepressant medications\"]}","documentGroup":null,"targeting":{"content_placement":["topics/child-adolescent-psychiatry","topics/major-depressive-disorder","topics/depression","topics/transcranial-magnetic-stimulation"],"document_url":["neurostar-tms-for-adolescents-with-major-depressive-disorder-a-look-at-the-new-data"],"document_group":null,"rootDocumentGroup":[],"issue_url":"","publication_url":""},"relatedArticles":[{"title":"Coping with Diagnostic Uncertainty in Mixed States: Comparing Treatment 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We designed the Inspire to enable both experienced TMS providers as well as those who are new to TMS.”","_key":"7e292c3ae50d0"}]},{"_key":"60a17cfe9b3e","markDefs":[],"children":[{"_key":"f8476272d33e0","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal"},{"children":[{"marks":[],"text":"The use of TMS for treating MDD and OCD is increasing, driven by new studies demonstrating its effectiveness over other treatments. One-third of patients with MDD experience inadequate response to pharmacotherapy and psychotherapy. After 2 failed antidepressant trials, a different therapeutic modality might be beneficial, including TMS.","_key":"1d20b4e15a220","_type":"span"},{"_type":"span","marks":["superscript"],"text":"2","_key":"8d2023545ca0"}],"_type":"block","style":"normal","_key":"dab3dcc68cde","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"343b05c8d4dc0"}],"_type":"block","style":"normal","_key":"0133f2f3183c"},{"_type":"block","style":"normal","_key":"be3c4a50b4db","markDefs":[],"children":[{"_type":"span","marks":[],"text":"The Inspire system allows clinicians to provide easy to use, cost effective, portable, high-power, air-cooling, back-to-back customizable TMS treatments. The Inspire system is built using Magstim TMS technology, which is cited in more than 20,000 peer reviewed research papers. It is used in hospitals, clinics, and research centers worldwide. The system also leverages intuitive preset clinical workflows to simplify the treatment process, and delivers precise results with no pulse decay, ensuring the correct dosage. Magstim’s air-cooled coil reduces downtime and eliminates additional cooling expenses. Furthermore, its advanced data analytics tools improve the efficacy of the treatment.","_key":"ca977f7168810"}]},{"style":"normal","_key":"e8a45ab03972","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"2775eb0637110"}],"_type":"block"},{"markDefs":[],"children":[{"text":"TMS is now mostly covered by insurance, including Medicare. Additionally, the range of clinicians available to utilize TMS has expanded: many states now permit both psychiatrists and psychiatric nurse practitioners to prescribe and treat patients with TMS.","_key":"3fcc15322f8a0","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"feca110242a1"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"2364098bb5f80"}],"_type":"block","style":"normal","_key":"910fba3ea6b5"},{"_type":"block","style":"normal","_key":"e6aa08b46f4e","markDefs":[],"children":[{"text":"Earlier this year, the FDA granted clearance to Magstim’s TMS technology, Horizon 3.0 with StimGuide Pro, which is indicated for adults with MDD who failed to achieve improvement from prior antidepressant trials, and for adults with OCD. Horizon 3.0 with StimGuide Pro is the first integrated TMS system with navigation, adding new advanced camera technology designed to allow for precise treatment targeting and a central screen intended to reduce complexity. The Horizon 3.0 TMS Therapy System has also received prior clearance for decreasing comorbid anxiety symptoms in adults with MDD.","_key":"d8b277b433540","_type":"span","marks":[]},{"marks":["superscript"],"text":"3","_key":"f3016e716505","_type":"span"}]},{"style":"normal","_key":"1180f5f3f3a4","markDefs":[],"children":[{"text":"","_key":"c8c35265901d0","_type":"span","marks":[]}],"_type":"block"},{"_type":"block","style":"normal","_key":"26e2d9f4c4ab","markDefs":[],"children":[{"_type":"span","marks":[],"text":"“We are passionate about helping patients worldwide to improve their mental health,” said Stolec-Campo. “We worked with leading psychiatrists, clinicians, and researchers to develop this system, enabling advanced treatments and simplified practice workflows. TMS is life-saving technology that provides nonpharmacological, noninvasive treatments.”","_key":"d3b3092165450"},{"_type":"span","marks":["superscript"],"text":"3","_key":"c4c7b41d27de"}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"27f104c38b610"}],"_type":"block","style":"normal","_key":"c4cd1edba0b4"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"A psychiatric provider, Khaled Bowarshi, MD, also shared this about Magstim’s products: “Our TMS patients have experienced a high-degree of success, allowing them to change their lives. We strive to provide the best technology for our patients.”","_key":"52d407ed17c80"},{"marks":["superscript"],"text":"3","_key":"dbcf56d89d93","_type":"span"}],"_type":"block","style":"normal","_key":"c8b6c205010a"},{"markDefs":[],"children":[{"text":"","_key":"2ca4777b5db30","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"b3d33919e823"},{"markDefs":[],"children":[{"_key":"9bc265a7906e0","_type":"span","marks":[],"text":"“Magstim engineered the very first commercially available TMS research technology, and we remain committed to our foundation of research,” said Stolec-Campo. “We are unique in the industry because we do not charge pay per use fees, we maintain a dedicated service and support team, and we manufacture our own technology.”"},{"_type":"span","marks":["superscript"],"text":"1","_key":"d5d95612d94e"}],"_type":"block","style":"normal","_key":"09ef262e3ef7"},{"children":[{"_type":"span","marks":[],"text":"","_key":"cd374e6d440a0"}],"_type":"block","style":"normal","_key":"cbaabaea23f8","markDefs":[]},{"_type":"block","style":"normal","_key":"88a4534699cd","markDefs":[],"children":[{"marks":["strong"],"text":"References","_key":"a0665909f4ec0","_type":"span"}]},{"markDefs":[{"blank":true,"_type":"link","href":"https://finance.yahoo.com/news/fda-clears-magstim-horizon-inspire-131100376.html?guccounter=1\u0026guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8\u0026guce_referrer_sig=AQAAADsGQh9CoEGLER07kXOIc75FwG-YYZHAb0JfFDPBsaE40Ac9rHzacpO2L9u5AYq1V4s6tA0AAuxdM5Gzb49f0MSl2D-OJjE871sltULYhbWs4bB_dM6oZ-3rkFjpTBTDAtvfTgvDRjHRJCdim5A5qN_X_JEII5G2g-6wWyevN3Ff","_key":"36d17c602377"}],"children":[{"marks":[],"text":"1. 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