Efficacy and safety results from the first pivotal phase 3 randomized controlled trial of MDMA-assisted psychotherapy for treatment of severe chronic PTSD

Bessel van der Kolk has presented these pivotal MAPS Phase 3 findings on MDMA-assisted psychotherapy at the recent European Psychiatric Association Congress.

Medscape Psychiatry commented: "Adding 3,4-methylenedioxymethamphetamine (MDMA) to integrative psychotherapy may significantly improve symptoms and well-being for patients with severe posttraumatic stress disorder (PTSD), including those with the dissociative subtype, new research suggests.  MAPP1 is the first phase 3 randomized controlled trial of MDMA-assisted therapy in this population. Participants who received the active treatment showed greater improvement in PTSD symptoms, mood, and empathy in comparison with participants who received placebo.  MDMA was "extremely effective, particularly for a subpopulation that ordinarily does not respond well to conventional treatment," study co-investigator Bessel van der Kolk, MD, professor of psychiatry at Boston University School of Medicine, Boston, Massachusetts, told delegates attending the virtual European Psychiatric Association (EPA) 2021 Congress. Results showed that both the MDMA and placebo groups experienced a statistically significant improvement in PTSD symptoms, "but MDMA had a dramatically significant improvement, with an effect size of over 0.9," Kolk said.  The MDMA group also reported enhanced mood and well-being, increased responsiveness to emotional and sensory stimuli, a greater sense of closeness to other people, and a greater feeling of empathy.  Patients also reported having heightened openness, "and clearly the issue of empathy for themselves and others was a very large part of the process," said Kolk.  "But for me, the most interesting part of the study is that the Adverse Childhood Experiences scale had no effect," he noted. In other words, "the amount of childhood adverse experiences did not predict outcomes, which was very surprising because usually those patients are very treatment resistant."  Kolk added that the the dissociative subtype of PTSD was first described in DSM-5 and that patients are "notoriously unresponsive to most unconventional treatments."  In the current study, 13 patients met the criteria for the subtype, and investigators found they "did better than people with classical PTSD," Kolk said. He added that this is a "very, very important finding for MDMA-assisted psychotherapy" In a pooled phase 2 data analysis, 82% of patients reported a significant improvement by the end of treatment; 56% reported that they no longer had PTSD.  In addition, 67% of patients no longer met diagnostic criteria for PTSD. These included patients who had crossed over to active treatment from the placebo group."

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