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This therapeutic exploratory trial (n=30, withdrawn), sponsored by MAPS Europe B.V., Netherlands, aimed to assess the long-term safety and persistence of effectiveness of manualized MDMA-assisted therapy for the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).
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’. shop with us…

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

–

Psychosis History

–

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.