This Phase 2 pilot study examined the safety and efficacy of MDMA-assisted psychotherapy in 23 subjects with chronic, treatment-resistant PTSD.
The study assessed the change in symptoms of PTSD, as measured by the Clinical Administered PTSD Scale (CAPS) as well as symptoms of depression, as measured by the Beck Depression Inventory II (BDI-II) from baseline enrollment to one month after the second MDMA-assisted psychotherapy session (primary endpoint).
Participants who received the comparator dose of MDMA (40 mg) were given the option to enroll in Stage 2, where they underwent three open-label MDMA-assisted psychotherapy sessions with an active dose of MDMA. People who received either of the active doses of MDMA in Stage 1 had a third MDMA-assisted psychotherapy session with another active dose of MDMA.
Trial Details
Trial Number
Sponsors & Collaborators
MAPSMAPS stands for Multidisciplinary Association for Psychedelic Studies, it's the front runner in making psychedelics a legal way to use (and improve) in therapy.
Papers
Discontinuation of medications classified as reuptake inhibitors affects treatment response of MDMA-assisted psychotherapyA pooled analysis of participants (n=50) in Phase II MDMA trials for PTSD found that recent tapering off SSRIs may reduce treatment response (CAPS-IV score).
MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials
This pooled analysis (n=105; s=6) of MAPS' Phase II trials finds significant improvements (Cohen's d=0.8) and no significant adverse effects with MDMA-assisted therapy for PTSD. This analysis has been done to support starting the Phase III trials (which have taken place).
Long-term Follow-Up Outcomes of MDMA-assisted Psychotherapy for Treatment of PTSD: A Longitudinal Pooled Analysis of Six Phase 2 Trials
This long-term follow-up study (n=107) examines the effects of MDMA-assisted psychotherapy on PTSD symptoms. It finds a significant reduction in PTSD symptoms both at treatment exit and at least 12 months post-treatment, with 67% of participants no longer meeting PTSD criteria at long-term follow-up.
3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: a randomized phase 2 controlled trial
This double-blind, between-subjects study (n=26) on the treatment of posttraumatic stress disorder (PTSD) compared the effectiveness of two higher (100-125mg) with one lower dose (40mg) of MDMA in combination with psychotherapy. One month after two sessions, the higher doses of MDMA showed the largest reduction on a PTSD Scale. At the 12-month follow-up, PTSD symptoms remained lower than baseline with 75% of the participants not meeting PTSD criteria.
Measures Used
Clinician-Administered PTSD Scale for DSM-5The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is often considered the gold standard in PTSD assessment. The 30-item structured interview was developed by staff at the U.S. Department of Veterans Affairs National Centre for PTSD. CAPS can be used to make a current diagnosis, lifetime diagnosis or assess PTSD symptoms over the past week in accordance with DSM-5 criteria.
Beck Depression Inventory
The Beck Depression Inventory (BDI) contains 21 self-report items, completed using a multiple-choice format. Scores range from 0-63 with higher scores associated with more severe depression.