Clinical TrialPTSDCompleted

Long-Term Safety and 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 using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) as a measure of PTSD symptom severity

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Target Enrollment
186 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

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.

Study Arms & Interventions

LTFU follow-up

experimental

Participants with past PTSD who received IMP in the main study

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Enrolled in a MAPS-sponsored study of MDMA-assisted therapy for the treatment of PTSD
  • 2. Have received Investigational Medicinal Product (IMP) in at least one Experimental Session in the main study
  • 3. Agree to be contacted by study team at least six months after the last Experimental Session in the main study to schedule and participate in LTFU visits

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Are not able to give adequate informed consent
  • 2. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    observational
  • Design
    Non-randomized
  • Target Enrollment186 participants
  • Timeline
    Start: 2021-03-01
    End: 2025-03-01
  • Topic
    PTSD

Locations

USCF — San Francisco, California, United States
Dr. Simon Amar Inc — Montreal, Quebec, Canada
Beer Yaakov Mental Health Center — Be’er Ya‘aqov, Israel
Tel Hashomer — Tel Aviv, Israel

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