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
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.
Participants with past PTSD who received IMP in the main study