An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 12
- 主要终点
- Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score
研究概览
简要总结
This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts.
- Part A is open-label and will enroll up to 15 participants with PTSD
- Part B is randomized (1:1:1), single-blind and will enroll up to 45 participants with PTSD
Eligible participants will enter a 3-week Treatment Period (Part A) or 4-week Treatment Period (Part B) where they will receive methylone once weekly. Following the Treatment Period, participants will enter a 6-week Follow-up Period (Part A) or 8-week Follow-up Period (Part B).
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Meets DSM-5 criteria for severe PTSD diagnosis, with a symptom duration of at least 6 months.
- •Tried at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
- •Proficient in reading and writing in local language sufficient to complete 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
- •Smokes an average of >10 cigarettes and/or e-cigarettes per day.
- •Uncontrolled hypertension at Screening.
- •Use of prohibited concomitant medications or therapies.
- •Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.
研究组 & 干预措施
TSND-201 Low Dose
Part B only
干预措施: Methylone (Drug)
TSND-201 Mid Dose
Part B only
干预措施: Methylone (Drug)
TSND-201 High Dose
Part B only
干预措施: Methylone (Drug)
结局指标
主要结局
Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score
时间窗: 9 weeks (Part A) / 12 weeks (Part B)
The CAPS-5 is a structured interview designed to assess PTSD symptom severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.
次要结局
- Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score(9 weeks (Part A) / 12 weeks (Part B))
- Change from Baseline in Sheehan Disability Scale (SDS)(9 weeks (Part A) / 12 weeks (Part B))
- Change from Baseline in PTSD Checklist for DSM-5 (PCL-5)(9 weeks (Part A) / 12 weeks (Part B))
- Incidence of treatment-emergent adverse events (TEAEs)(9 weeks (Part A) / 12 weeks (Part B))