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The first Phase 3 trial of MDMA-assisted therapy for posttraumatic stress disorder (PTSD) replicated and expanded on Phase 2 results indicating MDMA-assisted therapy may be an effective and cost-saving treatment for PTSD resulting from any cause. Nature Medicine is expected to publish the peer-reviewed paper detailing the results of the study sponsored by the Multidisciplinary Association of Psychedelic Studies (MAPS) and conducted by MAPS Public Benefit Corporation - MAPS PBC, a wholly-owned subsidiary of MAPS.
In this first Phase 3 trial of any psychedelic-assisted therapy, participants who received MDMA-assisted therapy reported a significant reduction in PTSD symptoms compared to those who received placebo with therapy (p<0.0001), successfully achieving the prespecified primary endpoint for the trial. Among the participants in the MDMA-assisted therapy group, 67% no longer qualified for PTSD diagnosis after three MDMA-assisted therapy sessions and 88% of participants experienced a clinically significant reduction in symptoms, while in the placebo group, 32% no longer qualified for PTSD diagnosis at the two-month follow-up and 60% experienced a clinically significant reduction in symptoms.
The randomized, blinded, Phase 3 trial, designed under a Special Protocol Assessment with the FDA, treated 90 patients with severe, chronic PTSD. Participants were randomized to receive three sessions of either MDMA or placebo with identical talk therapy. Forty-six participants received MDMA therapy and 44 participants received therapy with placebo. A second Phase 3 clinical trial is currently enrolling participants.
Read the full press release on our website: maps.org/20210503b
