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Mdma Clinical Trials

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

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Id: NCT05066282

Organisation Name: Multidisciplinary Association for Psychedelic Studies

Overal Status: Enrolling by invitation

Start Date: March 1, 2021

Last Update: October 13, 2022

Lead Sponsor: Multidisciplinary Association for Psychedelic Studies

Brief Summary: Data from a series of Phase 2 and 3 studies of MDMA-assisted therapy conducted by the sponsor provide preliminary evidence that chronic Posttraumatic Stress Disorder (PTSD), independent of cause, is treatable with up to three sessions of MDMA-assisted therapy. 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. Additionally, this study will gather data to support health economics and cost effectiveness analyses of this treatment. Participants who have received at least one dose of Investigational Medicinal Product (IMP) in the main study will be eligible to participate in this study.

  • PTSD

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