Psilocybin for the Treatment of Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Adverse Events
研究概览
简要总结
The goal of this study is to assess the effectiveness of psilocybin for the treatment of Major Depressive Disorder and potential therapeutic mechanisms. Enrolled participants will receive a single active dose of psilocybin, or a dose considered high enough to treat depression, administered orally with accompanying psychological support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently meeting DSM-V Criteria for a Major Depressive Episode of at least mild-moderate severity
- •Aged 18-85
- •Ability and willingness to attend study visits and complete study assessments
排除标准
- •Presence of medical conditions at screening that may affect the safe administration of psilocybin (including, but not limited to: AST/ALT > 150, QTc > 450ms, MELD > 9)
- •Depression deemed secondary to a severe medical condition
- •Recent use of any classical psychedelic drug or MDMA
- •Recent use of any interventional psychiatric treatment (including: ECT, ketamine, esketamine, TMS)
- •Intention to begin any new treatment for depression prior to primary outcome determination
- •Use of any excluded medication
- •Active substance use disorder
- •Presence of any psychiatric condition that may interfere with the safe administration of psilocybin
- •Active suicidal ideation
研究组 & 干预措施
Psilocybin Active Dose Treatment A
Psilocybin
干预措施: Psilocybin (Drug)
Psilocybin Active Dose Treatment B
Psilocybin
干预措施: Psilocybin (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to 12 weeks post-treatment
Rates of adverse events related to treatment, as determined by multiple data collection mechanisms
Study Retention and Completion
时间窗: Throughout study participation (12-17 weeks)
Rates of successful attendance of study visits and completion of study
MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline
时间窗: 3 weeks post-treatment
Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms
次要结局
- MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline(12 weeks post-treatment)
研究者
Ginger E Nicol
Associate Professor of Psychiatry
Washington University School of Medicine