An Open-Label, Phase 2, Multicenter Feasibility Study of Manualized MDMA-Assisted Psychotherapy With an Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects With Posttraumatic Stress Disorder
This study is the first multi-center study of MDMA-assisted therapy for PTSD in Europe and will explore reproducibility of findings from FDA-regulated Phase 2 trials to confirm the Phase 3 study design. Taking place in the United Kingdom, Germany, Portugal, Norway, the Czech Republic, and the Netherlands, this open-label Phase 2 study of MDMA-assisted therapy for PTSD will serve as the lead-in to the planned Phase 3 study in Europe. This study will also provide cross-cultural validation data on the updated version of the Primary Outcome measure, the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), which will be used in the Phase 3 study. In addition, the study will gather supportive data on the safety and effectiveness of manualized MDMA-assisted therapy while providing an opportunity for clinical supervision to planned Phase 3 therapy teams.