A Multicenter Phase 2, 12-week Double-blind, Placebo-controlled, Randomized, Parallel-group Study of JZP150 for the Treatment of Posttraumatic Stress Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 49
- 主要终点
- Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score
研究概览
简要总结
This is a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter study of the safety and efficacy of JZP150 in the treatment of adult participants with post-traumatic stress disorder (PTSD).
详细描述
JZP150 is an oral, highly selective inhibitor of fatty acid amide hydrolase (FAAH). In this phase 2 study, participants with PTSD will receive either placebo or 1 of 2 doses of JZP150. The primary objective of the study will assess the change in PTSD symptoms from baseline to Week 12 using the Clinician Administered PTSD Scale (CAPS-5).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 18 to 70 years
- •Participants must be outpatients with a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) defined PTSD confirmed by the clinical interview
- •PTSD is primary diagnosis
排除标准
- •Acute or unstable medical condition, behavioral or psychiatric disorder (other than PTSD)
- •Suicidal behavior in the past 2 years or active suicidal ideation in the past 6 months
- •Ongoing traumatic event or exposure to a traumatic event <3 months prior to Screening
- •Index event > 12 years
- •Index event is combat trauma
研究组 & 干预措施
JZP150 0.3 mg
Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks.
干预措施: JZP150 (Drug)
JZP150 4.0 mg
Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks.
干预措施: JZP150 (Drug)
Placebo
Participants who will be randomized to receive placebo orally once daily for up to 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score
时间窗: Baseline to Week 12
Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) is a clinician administered, clinical interview where participants report on their symptoms of PTSD on a scale. The CAPS-5 total score ranges between 0 and 80. Higher scores indicate more severe PTSD symptoms. Change in CAPS-5 total score is being reported, where negative mean scores indicate an improvement in clinical outcome.
次要结局
- Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)(Baseline to Week 12)
- Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S)(Baseline to Week 12)