A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)
A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder of Moderate or Greater Severity
Sponsor: Resilient Pharmaceuticals
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-V (CAPS-5)
Time frame: Baseline to 18 weeks post baseline post enrollment confirmation
Secondary Endpoints
Change From Baseline to Primary Endpoint in Adapted Sheehan Disability Scale (SDS) Total Score
Eligibility Criteria
Inclusion Criteria: * Are at least 18 years old * Are fluent in speaking and reading the predominantly used or recognized language of the study site * Are able to swallow pills * Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions * Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable * Must agree to inform the investigators within 48 hours of any medical conditions and procedures * If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session * Must not participate in any other interventional clinical trials during the duration of the study * Must be willing to remain overnight at the study site after each…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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