6/28/23, 11:16 PM MAPP1 Pathway Feedback Search Clinical Topics Home Studies MAPP1 MAPP1 Disease Posttraumatic stress disorder Trial question What is the role of MDMA-assisted therapy in patients with severe posttraumatic stress disorder? Study design Multi-center Double blinded RCT Population Characteristics of study participants 66.0% female N = 90 34.0% male 90 patients (59 female, 31 male) Inclusion criteria: patients with severe posttraumatic stress disorder, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma Key exclusion criteria: primary psychotic disorder, bipolar I disorder, dissociative identity disorder, eating disorders with active purging, major depressive disorder with psychotic features, personality disorders, current alcohol and substance use disorders Interventions N=46 MDMA-assisted therapy (manualized MDMA-assisted psychotherapy with three preparatory and nine integrative therapy sessions) https://web.pathway.md/studies/rec3vf9xNXnGF8aMK 1/2 6/28/23, 11:16 PM MAPP1 Pathway N=44 placebo with therapy (inactive placebo-assisted psychotherapy with three preparatory and nine integrative therapy sessions) Primary outcome Reduction in posttraumatic stress disorder symptoms, as measured by Clinician-Administered PTSD Scale for DSM-5 at 18 weeks 24.4 24.4 18.3 13.9 12.2 6.1 Significant increase 0.0 MDMA-assisted therapy Placebo with therapy Significant increase in reduction in posttraumatic stress disorder symptoms, as measured by the Clinician-Administered PTSD Scale for DSM-5 at 18 weeks (24.4 vs. 13.9; AD 10.5, 95% CI 5.25 to 15.75) Secondary outcomes Significant increase in reduction in functional impairment score, as measured with the Sheehan Disability Scale (3.1 vs. 2; AD 1.1, 95% CI 0.25 to 1.95) Significant increase in reduction in depressive symptoms, as measured by the Beck Depression Inventory II (19.7 vs. 10.8; AD 8.9, 95% CI 3.12 to 14.68) Safety outcomes No significant differences in suicidality, QT prolongation. Significant difference in the percentage of patients with remission after three sessions (33% vs. 5%). Conclusion In patients with severe posttraumatic stress disorder, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma, MDMA-assisted therapy was superior to placebo with therapy with respect to reduction in posttraumatic stress disorder symptoms, as measured by the Clinician-Administered PTSD Scale for DSM-5 at 18 weeks. Reference Jennifer M Mitchell, Michael Bogenschutz, Alia Lilienstein et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021 Jun;27(6):1025-1033. Open reference URL https://web.pathway.md/studies/rec3vf9xNXnGF8aMK 2/2