Efficacy and safety results from the first pivotal phase 3 randomized controlled trial of mdma-assisted psychotherapy for treatment of severe chronic PTSD
European Psychiatry April 1, 2021 B. Van der Kolk
A randomized, double-blind, Phase 3 trial tested three sessions of flexible-dose MDMA or placebo as an adjunct to psychotherapy in 100 participants with severe PTSD. The primary outcome was change in PTSD symptoms and functional impairment at 18 weeks. MDMA was well tolerated, with some treatment-emergent adverse events more frequent in the MDMA group, and three serious adverse events of suicidal ideation or behavior occurred. The authors will present effect sizes and responder analyses. If MDMA-assisted psychotherapy significantly reduces PTSD symptoms and functional impairment, the results could support marketing authorization applications worldwide.