This therapeutic exploratory trial (n=30, withdrawn), sponsored by MAPS Europe B.V., Netherlands, aimed to assess the long-term safety and persistence of effectiveness of manualized MDMA-assisted therapy for the treatment of posttraumatic stress disorder (PTSD).
Long-term follow-up study of participants previously enrolled in MAPS Europe MDMA-assisted therapy trials for PTSD to assess persistence of treatment effect and long-term safety; no IMP is administered in this follow-up study.
Primary outcome is CAPS-5 total severity score assessed by an independent rater (video-recorded); secondary outcome includes Sheehan Disability Scale for PTSD (MAPS-adapted). Assessments occur at Visit 1 (LTFU IR assessment) approximately ≥6 months after last experimental session in the parent study.
Planned multinational study with sites in Czechia, Germany, Netherlands, Norway and the United Kingdom; EudraCT record lists the trial as 'Prematurely Ended'.