Clinical TrialPTSDWithdrawn

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

This therapeutic exploratory trial (n=30, withdrawn), sponsored by MAPS Europe B.V., Netherlands, aimed to assess the long-term safety and persistence of effectiveness of manualized MDMA-assisted therapy for the treatment of posttraumatic stress disorder (PTSD).

Target Enrollment
37 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Long-term follow-up study of participants previously enrolled in MAPS Europe MDMA-assisted therapy trials for PTSD to assess persistence of treatment effect and long-term safety; no IMP is administered in this follow-up study.

Primary outcome is CAPS-5 total severity score assessed by an independent rater (video-recorded); secondary outcome includes Sheehan Disability Scale for PTSD (MAPS-adapted). Assessments occur at Visit 1 (LTFU IR assessment) approximately ≥6 months after last experimental session in the parent study.

Planned multinational study with sites in Czechia, Germany, Netherlands, Norway and the United Kingdom; EudraCT record lists the trial as 'Prematurely Ended'.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • 1. At least 18 years of age at the time of signing the informed consent.
  • 2. Previously enrolled in a MAPS Europe sponsored study of MDMA-assisted therapy for the treatment of PTSD.
  • 3. Have received at least one dose of Investigational Medicinal Product (IMP) in the parent study.
  • 4. Agree to be contacted by a study team at least 6 months after the last Experimental Session in the parent study to schedule and participate in long-term follow-up (LTFU) assessments.
  • 5. Agree to have Independent Rater assessments video-recorded.
  • 6. Capable of giving signed informed consent and complying with requirements and restrictions described in the informed consent form and protocol.

Exclusion Criteria

  • 1. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with study participation.

Study Details

  • Status
    Withdrawn
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment37 participants
  • Timeline
    Start: 2022-05-09
    End: 2024-12-30
  • Topic
    PTSD

Locations

CzechiaGermanyNetherlandsNorwayUnited Kingdom

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