MAPP2
Trial question
What is the role of MDMA-assisted therapy in patients with moderate-to-severe PTSD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
71.0% female
29.0% male
N = 104
104 patients (74 female, 30 male)
Inclusion criteria: patients diagnosed with moderate-to-severe PTSD
Key exclusion criteria: uncontrolled hypertension; history of additional risk factors for torsade de pointes; significant medical disorders; symptomatic liver disease; hyponatremia or hyperthermia
Interventions
N=53 MDMA-assisted therapy (at a split dose of 120-180 mg for approximately 3 months)
N=51 placebo with therapy (matching placebo with therapy for 3 months)
Primary outcome
Mean reduction in Clinician-Administered PTSD Scale for DSM-5 total severity score at week 18
23.7
14.8
23.7 points
17.8 points
11.8 points
5.9 points
0.0 points
MDMA-assisted
therapy
Placebo with
therapy
Significant
increase ▲
Significant increase in mean reduction in Clinician-Administered PTSD Scale for DSM-5 total severity score at week 18 (23.7 points vs. 14.8 points; AD 8.9 points, 95% CI 4.12 to 13.7)
Secondary outcomes
Significant increase in mean reduction in Sheehan Disability Scale score (3.3 points vs. 2.1 points; AD 1.2 points, 95% CI 0.14 to 2.26)
Safety outcomes
No significant difference in severe treatment-emergent adverse events.
Conclusion
In patients diagnosed with moderate-to-severe PTSD, MDMA-assisted therapy was superior to placebo with therapy with respect to mean reduction in Clinician-Administered PTSD Scale for DSM-5 total severity score at week 18.
Reference
Jennifer M Mitchell, Marcela Ot'alora G, Bessel van der Kolk et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med. 2023 Oct;29(10):2473-2480.
Open reference URL