An Open-Label, Multi-Site Phase 2 Study of the Safety and Effect of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder (Canada)
This multi-site, open-label, Phase 2, lead-in study assessed the safety and effects of MDMA-assisted therapy in N=4 participants diagnosed with at least severe PTSD. Therapy teams that were identified and trained to work on the sponsor’s planned Phase 3 studies treated at least one open-label participant in this study. A flexible dose of MDMA (100 to 125 mg), followed by a supplemental half-dose, unless contraindicated, was administered during the Treatment Period with manualized therapy in three open-label monthly Experimental Sessions. This ~12-week Treatment Period was preceded by three Preparatory Sessions. During the Treatment Period, each Experimental Session was followed by three Integrative Sessions of non-drug therapy. The primary outcome measure was the change in the Clinician Administered PTSD Scale for DSM 5 (CAPS-5) total severity scores from Baseline to Visit 19. The secondary outcome measure was the change in the customized version of the Sheehan Disability Scale (SDS) for PTSD for the MAPS studies total scores from Baseline to Visit 19.
The change in CAPS-5 total severity scores from Baseline to Visit 19 was -25.00 (SD: 2.58) and the change in SDS total score over this period was -4.7 (SD: 1.46).