CompletedN/AMDMA
Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD
Sponsored by Lykos Therapeutics
NCT ID
NCT05066282
Target Enrollment
186 participants
Start Date
2021-03-01
Est. Completion
2024-05-21
About This Study
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.
Conditions Studied
Eligibility
Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: 1. Enrolled in a MAPS-sponsored study of MDMA-assisted therapy for the treatment of PTSD 2. Have received Investigational Medicinal Product (IMP) in at least one Experimental Session in the main study 3. 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 Exclusion Criteria: 1. Are not able to give adequate informed consent 2. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation
Study Locations (4)
USCF
San Francisco, California, United States
Dr. Simon Amar Inc
Montreal, Quebec, Canada
Beer Yaakov Mental Health Center
Be’er Ya‘aqov, Israel
Tel Hashomer
Tel Aviv, Israel