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

Enrolling by invitationRegisteredCTG

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 Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) as a measure of PTSD symptom severity

Details

This long-term follow-up (LTFU) cohort study assesses durability of response to MDMA-assisted therapy in participants with PTSD who received at least one dose of IMP in a prior clinical trial, with assessments at least six months after last experimental session.

Primary outcome is change in CAPS-5 Total Severity Score from the parent study baseline and termination to LTFU assessments; additional data will support health-economic and cost-effectiveness analyses.

Topics:PTSD

Registry

Registry linkNCT05066282