NCT07836647招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
研究概览
简要总结
This study is evaluating the safety and efficacy of TSND-201 in adults with PTSD. Eligible participants will enter a 4-week Treatment Period where they will be randomized 1:1:1 to receive one of two doses of TSND-201 or placebo, once per week. Following the Treatment Period, participants will enter an 8-week Follow-up Period.
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
- •Meets DSM-5 criteria for current PTSD diagnosis, with a symptom duration of at least 6 months.
- •Tried at least one pharmacological treatment for PTSD or trauma-focused psychotherapy.
- •Proficient in communication (verbal and reading) to complete interviews and written questionnaires.
- •Free from any other clinically significant illness or disease.
排除标准
- •Primary diagnosis of any other DSM-5 disorder.
- •Body mass index (BMI) <18kg/m2 or ≥40 kg/m
- •Unable to refrain from nicotine use for at least 8 hours.
- •Use of prohibited concomitant medications or therapies.
- •Current or previous history of clinically significant cardiovascular (including current uncontrolled hypertension) / cerebrovascular conditions.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
TSND-201, Dose Level 1
Experimental
干预措施: TSND-201 (Drug)
TSND-201, Dose Level 2
Experimental
干预措施: TSND-201 (Drug)
结局指标
主要结局
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
时间窗: Up to 12 Weeks
CAPS-5 is a structured interview designed to assess PTSD symptoms severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.
次要结局
未报告次要终点
研究者
研究点 (2)
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