MAPP1
Trial question
What is the role of MDMA-assisted therapy in patients with severe PTSD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
66.0% female
34.0% male
N = 90
90 patients (59 female, 31 male)
Inclusion criteria: patients with severe PTSD, 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)
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
13.9
24.4 points
18.3 points
12.2 points
6.1 points
0.0 points
MDMA-assisted
therapy
Placebo with
therapy
Significant
increase ▲
Significant increase in reduction in PTSD symptoms, as measured by the Clinician-Administered PTSD Scale for DSM-5 at 18 weeks (24.4 points vs. 13.9 points; AD 10.5 points, 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 points vs. 2 points; AD 1.1 points, 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 patients with remission after three sessions (33% vs. 5%).
Conclusion
In patients with severe PTSD, 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 PTSD 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.
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