A One-Year Observational Follow-up Study of Participants With Major Depressive Disorder Following a Randomized, Double-Blind Single-Dose of Psilocybin or Niacin-Control
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Montgomery-Asberg Depression Rating Scale
研究概览
简要总结
This is a Phase 2 double-blind, long-term observational follow-up study of participants from Study PSIL201. Participants providing informed consent were enrolled into this study and completed web surveys and telephone interviews conducted by one central site at the following time intervals: months 3 and 6 (± 7 days for each assessment) and months 10 and 12 (± 14 days for each assessment).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment and randomization in Study PSIL201
- •Ability and willingness to provide informed consent prior to initiation of any study-related procedures
排除标准
- •Inability or unwillingness to complete study procedures, including regular completion of web surveys and telephone interviews with study personnel
研究组 & 干预措施
Niacin-Control
Participants randomized to a single oral dose of niacin 100 mg (active comparator) in Study PSIL201.
干预措施: No intervention will be administered as part of this study. (Other)
Single-Dose of Psilocybin
Participants randomized to a single oral dose of psilocybin 25 mg in Study PSIL201.
干预措施: No intervention will be administered as part of this study. (Other)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale
时间窗: 6 Months post-dosing in PSIL201
Between-group difference in mean change from baseline (prior to dosing in PSIL201) in Montgomery-Asberg Depression Rating Scale (MADRS) to 6 months post-dosing in Study PSIL201
次要结局
未报告次要终点