Long-Term Safety and Persistence of Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Posttraumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 4
- 主要终点
- Clinician Administered PTSD Scale for DSM-V (CAPS-5) Total Severity Score (actual or imputed) from the main study Baseline and Study Termination to assessment in the current LTFU study
研究概览
简要总结
The goal of this long-term follow-up study is to measure how long effects of MDMA-assisted therapy last in participants with PTSD who were treated in a prior Phase 3 clinical trial of MDMA-assisted therapy.
The main question it aims to answer is: Does MDMA-assisted therapy result in lasting reductions in PTSD symptoms?
Participants who have received at least one dose of MDMA-assisted therapy will take a PTSD assessment at least six months after their last MDMA-assisted therapy session in the main study.
详细描述
This non-interventional study will serve as the long-term follow-up (LTFU) protocol for MDMA-assisted therapy clinical trials and will measure persistence of effectiveness using the CAPS-5 as a measure of PTSD symptom severity. The primary objective of this study is to evaluate the long-term effectiveness of MDMA-assisted therapy for treatment of PTSD as measured by the change in CAPS-5 Total Severity Score (actual or imputed) from the main study Baseline and Study Termination to LTFU IR Assessments (Visit 1). Additionally, this study will gather data to support health economics and cost effectiveness analyses of this treatment. Participants who have received at least one dose of Investigational Medicinal Product (IMP) in the main study will be eligible to participate in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Enrolled in a MAPS-sponsored study of MDMA-assisted therapy for the treatment of PTSD
- •Have received Investigational Medicinal Product (IMP) in at least one Experimental Session in the main study
- •Agree to be contacted by study team at least six months after the last Experimental Session in the main study to schedule and participate in LTFU visits
排除标准
- •Are not able to give adequate informed consent
- •Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation
结局指标
主要结局
Clinician Administered PTSD Scale for DSM-V (CAPS-5) Total Severity Score (actual or imputed) from the main study Baseline and Study Termination to assessment in the current LTFU study
时间窗: LTFU IR Assessments at Least 6 Months Since Last Experimental Session in Main Study (Visit 1)
The Clinician-Administered PTSD Scale for DSM-V (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
次要结局
未报告次要终点