EUCTR2021-005596-39-CZ进行中（未招募）1 期
ong-Term Safety and Persistence of Effectiveness of Manualized MDMA Assisted Therapy for the Treatment of Posttraumatic Stress Disorder - Long-term follow-up of MDMA-assisted therapy for PTSD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. At least 18 years of age at the time of signing the informed consent.
- •2. Previously enrolled in a MAPS Europe sponsored study of MDMA assisted therapy for the treatment of PTSD.
- •3. Have received at least one dose of Investigational Medicinal Product (IMP) in the parent study.
- •4. Agree to be contacted by a study team at least 6 months after the last Experimental Session in the parent study to schedule and participate in LTFU assessments.
- •5. Agree to have Independent Rater assessments video-recorded.
- •6. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •1. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with study participation.
研究者
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