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Single-Dose Psilocybin Treatment for Major Depressive Disorder

医学 灵霉素 重性抑郁障碍 加药 精神科 不利影响 安慰剂 自杀意念 萧条(经济学) 双相情感障碍 抗抑郁药 评定量表 内科学 毒物控制 心理学 致幻剂 焦虑 心情 伤害预防 发展心理学 替代医学 环境卫生 病理 经济 宏观经济学
作者
Charles L. Raison,Gerard Sanacora,Joshua Woolley,Keith G. Heinzerling,Boadie W. Dunlop,Randall Brown,Rishi Kakar,Michael Hassman,Rupal Trivedi,Reid Robison,Natalie Gukasyan,Sandeep Nayak,Xiao Hu,Kelley C. O’Donnell,Benjamin Kelmendi,Jordan Sloshower,Andrew Penn,Ellen Bradley,Daniel F. Kelly,Tanja Mletzko,Christopher R. Nicholas,Paul R. Hutson,Gary Tarpley,Malynn Utzinger,Kelsey Lenoch,Kasia Warchol,Theraysa Gapasin,M. Davis,Courtney Nelson-Douthit,Steffanie H Wilson,Carrie Brown,William Linton,Stephen Ross,Roland R. Griffiths
出处
期刊:JAMA [American Medical Association]
卷期号:330 (9): 843-843 被引量:32
标识
DOI:10.1001/jama.2023.14530
摘要

Importance Psilocybin shows promise as a treatment for major depressive disorder (MDD). Objective To evaluate the magnitude, timing, and durability of antidepressant effects and safety of a single dose of psilocybin in patients with MDD. Design, Setting, and Participants In this phase 2 trial conducted between December 2019 and June 2022 at 11 research sites in the US, participants were randomized in a 1:1 ratio to receive a single dose of psilocybin vs niacin placebo administered with psychological support. Participants were adults aged 21 to 65 years with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of MDD of at least 60 days’ duration and moderate or greater symptom severity. Exclusion criteria included history of psychosis or mania, active substance use disorder, and active suicidal ideation with intent. Participants taking psychotropic agents who otherwise met inclusion/exclusion criteria were eligible following medication taper. Primary and secondary outcomes and adverse events (AEs) were assessed at baseline (conducted within 7 days before dosing) and at 2, 8, 15, 29, and 43 days after dosing. Interventions Interventions were a 25-mg dose of synthetic psilocybin or a 100-mg dose of niacin in identical-appearing capsules, each administered with psychological support. Main Outcomes and Measures The primary outcome was change in central rater–assessed Montgomery-Asberg Depression Rating Scale (MADRS) score (range, 0-60; higher scores indicate more severe depression) from baseline to day 43. The key secondary outcome measure was change in MADRS score from baseline to day 8. Other secondary outcomes were change in Sheehan Disability Scale score from baseline to day 43 and MADRS-defined sustained response and remission. Participants, study site personnel, study sponsor, outcome assessors (raters), and statisticians were blinded to treatment assignment. Results A total of 104 participants (mean [SD] age, 41.1 [11.3] years; 52 [50%] women) were randomized (51 to the psilocybin group and 53 to the niacin group). Psilocybin treatment was associated with significantly reduced MADRS scores compared with niacin from baseline to day 43 (mean difference,−12.3 [95% CI, −17.5 to −7.2]; P <.001) and from baseline to day 8 (mean difference, −12.0 [95% CI, −16.6 to −7.4]; P < .001). Psilocybin treatment was also associated with significantly reduced Sheehan Disability Scale scores compared with niacin (mean difference, −2.31 [95% CI, 3.50-1.11]; P < .001) from baseline to day 43. More participants receiving psilocybin had sustained response (but not remission) than those receiving niacin. There were no serious treatment-emergent AEs; however, psilocybin treatment was associated with a higher rate of overall AEs and a higher rate of severe AEs. Conclusions and Relevance Psilocybin treatment was associated with a clinically significant sustained reduction in depressive symptoms and functional disability, without serious adverse events. These findings add to increasing evidence that psilocybin—when administered with psychological support—may hold promise as a novel intervention for MDD. Trial Registration ClinicalTrials.gov Identifier: NCT03866174
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