NCT05066282

Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD

Long-Term Safety and Persistence of Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Posttraumatic Stress Disorder

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 186 (actual)
• Sponsor: Lykos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• PTSD

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-05-16
• Completion: 2024-05-21
• First posted: 2021-10-04
• Last updated: 2024-10-30

Locations

4 sites across 3 countries: United States, Canada, Israel