NCT05220410已完成2 期
The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation
Sheppard Pratt Health System1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年3月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Modified Scale for Suicidal Ideation (MSSI)
研究概览
简要总结
This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 65 years of age at Screening
- •Diagnosis of Major Depressive Disorder (MDD)
- •Significant level of suicidal thoughts with active ideation and without immediate intent
- •Failure to respond to 2 medications in the current episode
排除标准
- •Current or past history of schizophrenia, psychotic disorder, bipolar disorder, borderline personality disorder, etc.
- •Current alcohol or substance use disorder
研究组 & 干预措施
Psilocybin
Experimental
25mg of Psilocybin
干预措施: Psilocybin (Drug)
结局指标
主要结局
Modified Scale for Suicidal Ideation (MSSI)
时间窗: Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9) and Week 12 (V10)
The MSSI is an 18-item clinician rated scale to assess the presence or absence of suicide ideation and the degree of severity of suicidal ideas. Each of the 18 items is rated on a scale of 0 to 3 where a higher score indicates greater suicidal severity.
次要结局
- Montgomery-Åsberg Depression Rating Scale (MADRS)(Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9), and Week 12 (V10))
- Concise Health Risk Tracking Self Report 12 Items (CHRT-SR)(Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9) and Week 12 (V10))
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), and Week 12 (V10))
- Clinical Global Impressions - Modified for Suicidal Ideation (CGI-SI)(Baseline (V2) to Week 3 (V7), and Week 12 (V10))
- Clinical Global Impression - Modified for Depression (CGI-D)(Baseline (V2) to Week 3 (V7) and Week 12 (V10))
研究者
Scott T. Aaronson, M.D
Director, Clinical Research Programs
Sheppard Pratt Health System
研究点 (1)
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