Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials.
Level 3 - non-randomized controlled study
Longitudinal pooled follow-up analysis of participants from six trials without a long-term control group (and retracted publication)
PubMed 32500209 · doi:10.1007/s00213-020-05548-2
What was done
This study pooled data across six phase 2 clinical trials evaluating MDMA-assisted psychotherapy for PTSD. Participants received two to three active doses of MDMA (75–125 mg) during blinded or open-label psychotherapy sessions, accompanied by non-drug therapy sessions. PTSD symptoms were evaluated via the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at baseline, treatment exit (1 to 2 months post-final active session), and long-term follow-up (LTFU; at least 12 months post-final active session) using a mixed-effect repeated-measures (MMRM) model. Participants also completed a long-term follow-up questionnaire assessing perceived benefits and harms.
What was found
CAPS-IV total severity scores decreased significantly from baseline to treatment exit (LS mean [SE] = -44.8 [2.82], p < 0.0001; Cohen's d = 1.58, 95% CI 1.24 to 1.91). Scores decreased further between treatment exit and LTFU (LS mean [SE] = -5.2 [2.29], p < 0.05; Cohen's d = 0.23, 95% CI 0.04 to 0.43). The proportion of participants no longer meeting PTSD diagnostic criteria increased from 56.0% at treatment exit to 67.0% at LTFU. Most participants reported subjective benefits, including improved relationships and well-being, while a minority reported harms.
Why it matters
The analysis suggests that symptom reductions achieved shortly after MDMA-assisted psychotherapy can persist for at least one year post-treatment.
Limits
The total participant sample size (n) is not reported in the abstract. The long-term follow-up phase lacked a concurrent control group, precluding attribution of durability solely to MDMA versus natural recovery, concurrent interventions, or psychotherapy alone. The pooled trials mixed blinded and open-label designs. Furthermore, this article is indexed with a publication type of Retracted Publication.
Cited by
- supports In a phase two study of MDMA-assisted therapy for severe PTSD, approximately two-thirds of participants no longer met diagnostic criteria for PTSD at the primary endpoint and at one-year follow-up.