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This therapeutic exploratory trial (n=30, withdrawn), sponsored by MAPS Europe B.V., Netherlands, aimed to assess the long-term safety and persistence of effectiveness of manualized MDMA-assisted therapy for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

Unfortunately, the trial was prematurely ended. It involved 30 adult participants, aged 18-64 years, and 7 elderly participants, aged 65 years and above, all diagnosed with PTSD. The trial did not involve any controlled or randomised aspects, being a long-term follow-up study with no investigational medicinal product given.

The main objective was to compare PTSD severity between groups who received MDMA versus Placebo during the parent study, based on assessments at Visit 1. The primary endpoint was the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th edition (CAPS-5) Total Severity Score, assessed at Visit 1. Secondary endpoints included the Sheehan Disability Scale for PTSD for MAPS Total score, also assessed at Visit 1.

The trial was conducted across six sites in the Czech Republic, Germany, Netherlands, Norway, and the United Kingdom. Unfortunately, the trial was prematurely ended, but prior to this decision, it had been authorised by the Competent Authority, with a favourable Ethics Committee Opinion.

Trial Details

This trial, sponsored by MAPS Europe B.V., aimed to assess the long-term safety and effectiveness of MDMA-assisted therapy for PTSD. It involved 30 adult and 7 elderly participants diagnosed with PTSD, comparing those who received MDMA to Placebo. The trial, prematurely ended, assessed PTSD severity using CAPS-5 and functional impairment with the Sheehan Disability Scale. Conducted across six sites in Europe, it received authorisation from the Competent Authority and had a favourable Ethics Committee Opinion.

NCT Number 2021-005596-39

Data attribution

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