A Pilot Study to Assess the Use of Methylone in the Treatment of PTSD IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 16
- 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, tolerability, and efficacy of methylone in adults with PTSD. The study will be conducted in two parts.
- Part A is open-label and will enroll up to 15 participants with PTSD
- Part B is randomized (1:1), double-blind, placebo-controlled and will enroll up to 64 participants with PTSD
Eligible participants will enter a 4-week Treatment Period where they will receive methylone once weekly for 4 weeks (4 treatment sessions). Following the Treatment Period, participants will enter a 6-week Follow-up Period which includes 3 reflection visits (Week 4, 5, and 6) and a final study visit at Week 10.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a symptom duration of at least 6 months
- •CAPS-5 score of ≥35 at Screening.
- •Failed 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) <18 kg/m2 or ≥40 kg/m
- •Smokes an average of >10 cigarettes and/or e-cigarettes per day
- •Uncontrolled hypertension at Screening
- •Use of a psychedelic (e.g., LSD, psilocybin, DMT, mescaline), or entactogens such as MDMA, within 12 months of Screening.
- •Use of an SSRI or other antidepressant within 8 weeks of screening.
- •Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.
研究组 & 干预措施
Methylone
干预措施: Methylone (Drug)
Placebo
干预措施: Placebo (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: up to 10 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.
Change From Baseline in CAPS-5 Total Severity Score
时间窗: up to 10 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
- Change from Baseline in PTSD Checklist for DSM-5 (PCL-5)(up to 10 weeks)
- Incidence of treatment-emergent adverse events (TEAEs)(up to 10 weeks)
- Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score(up to 10 weeks)
- Change from Baseline in Sheehan Disability Scale (SDS)(up to 10 weeks)