A Proof of Concept (POC) Clinical Trial for Post-Traumatic Stress Disorder (PTSD) With a First-In-Class Vasopressin 1a Receptor Antagonist (SRX246)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Assessment of overall clinical improvement
研究概览
简要总结
18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246 for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for 8 weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period between treatments. Subjects will be assessed at baseline and then every 2 weeks during the trial using the CAPS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically stable, current diagnosis of PTSD
排除标准
- •Medically unstable
研究组 & 干预措施
SRX246
SRX246 160 mg BID, oral administration, capsules, daily for 8 weeks
干预措施: SRX246 (Drug)
Placebo
oral administration, capsules, daily for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of overall clinical improvement
时间窗: 18 weeks
Measured using the Clinician Administered PTSD Scale (CAPS)
次要结局
- Number of participants with treatment-related adverse events(18 weeks)
- Reduction in depressive symptoms(18 weeks)
- Reduction in anger and aggression(18 weeks)
- Reduction in irritability(18 weeks)
- Improvement in overall functioning(18 weeks)
- Improvement in quality of life(18 weeks)
- Improvement in sleep quality(18 weeks)