Long-Term Safety and Persistence of Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Posttraumatic Stress Disorder
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. Additionally, this study will gather data to support health economics and cost effectiveness analyses of this treatment.
Participants who have undergone at least one Experimental Session of MDMA-assisted therapy in the main study will be eligible to participate in this study. No MDMA or therapy will be administered in this study. The study will consist of two visits where participants will meet with a study therapy team member to provide information about changes in health and medications either in person or via tele-assessment, followed by a tele-assessment visit with an Independent Rater (IR) who will administer the Clinician Administered PTSD Scale for DSM-V (CAPS-5) as a measure of PTSD symptom severity and the Sheehan Disability Scale (SDS), to measure functional impairment. Subsequently, participants will complete several self-report measures, administered electronically. The planned size is N=400 or more.
- Current Status: Active
- ClinicalTrials.gov Record