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Evaluating the Risk of Psilocybin for the Treatment of Bipolar Depression: A Review of the Research Literature and Published Case Studies
medRxiv - Psychiatry and Clinical Psychology Pub Date : 2021-08-19 , DOI: 10.1101/2021.04.02.21254838
David E. Gard , Mollie M. Pleet , Ellen R. Bradley , Andrew Penn , Matthew L. Gallenstein , Lauren S. Riley , Meghan DellaCrosse , Emily Garfinkle , Erin E. Michalak , Joshua D. Woolley

Growing evidence suggests that psilocybin, the active ingredient in hallucinogenic mushrooms, can rapidly and durably improve symptoms of depression, leading to recent breakthrough status designation by the FDA and legalization for mental health treatment in some jurisdictions. Depression in bipolar disorder is associated with significant morbidity and has few effective treatments. However, there is little available scientific data on the risk of psilocybin use in people with bipolar disorder. Individuals with bipolar disorder have been excluded from modern clinical trials, out of understandable concerns of activating mania or worsening the illness course. As psilocybin becomes more available, people with these disorders will likely seek psilocybin treatment for depression and have likely already been doing so in unregulated settings. Our goal here is to summarize the known risks of psilocybin use (and similar substances) in bipolar disorder and to systematically evaluate examples of published case history data, in order to critically evaluate the relative risk of psilocybin as a treatment for bipolar depression. We found 17 cases suggesting that there is potential risk for activating a manic episode, thereby warranting caution. Nonetheless, the relative lack of systematic data or common case examples indicating risk appears to show that a cautious trial, using modern trial methods focusing on appropriate set and setting, targeted at those lowest at risk for mania in the bipolar spectrum (e.g., bipolar 2 disorder), is very much needed, especially given the degree to which depression impacts this population.

中文翻译:

评估赛洛西宾治疗双相抑郁症的风险:研究文献和已发表案例研究回顾

越来越多的证据表明,致幻蘑菇中的活性成分裸盖菇素可以快速、持久地改善抑郁症的症状,导致最近获得 FDA 的突破性地位指定,并在某些司法管辖区将心理健康治疗合法化。双相情感障碍中的抑郁症与显着的发病率有关,并且几乎没有有效的治疗方法。然而,关于双相情感障碍患者使用裸盖菇素的风险的科学数据很少。患有躁郁症的人已被排除在现代临床试验之外,出于可以理解的激活躁狂症或恶化病程的担忧。随着裸盖菇素变得越来越可用,患有这些疾病的人可能会寻求裸盖菇素治疗抑郁症,并且可能已经在不受监管的环境中这样做了。我们的目标是总结在双相情感障碍中使用裸盖菇素(和类似物质)的已知风险,并系统地评估已发表的病历数据示例,以便批判性地评估裸盖菇素作为双相抑郁症治疗方法的相对风险。我们发现 17 个案例表明存在激活躁狂发作的潜在风险,因此需要谨慎。尽管如此,表明风险的系统数据或常见案例的相对缺乏似乎表明,谨慎的试验,使用现代试验方法侧重于适当的设置和设置,针对双相谱中躁狂症风险最低的人(例如,双相 2障碍),这是非常需要的,特别是考虑到抑郁症对这一人群的影响程度。
更新日期:2021-08-19
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