The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 25
- 主要终点
- MADRS Change From Baseline to Week 3, Sensitivity Analysis
研究概览
简要总结
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression
详细描述
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of TRD
排除标准
- •Other comorbidities
研究组 & 干预措施
Low dose
Low dose Psilocybin
干预措施: Psilocybin (Drug)
Medium dose
Medium dose Psilocybin
干预措施: Psilocybin (Drug)
High dose
High dose Psilocybin
干预措施: Psilocybin (Drug)
结局指标
主要结局
MADRS Change From Baseline to Week 3, Sensitivity Analysis
时间窗: Change from Baseline to Week 3
MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response \>= 50% decrease and remission \<= 10 total score.
Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3
时间窗: Change from Baseline to Week 3
MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response \>= 50% decrease and remission \<= 10 total score.
次要结局
未报告次要终点