An Open-Label, Multi-Site Phase 2 Study of the Safety and Effect of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder
This open-label lead-in Phase 2 study was intended to gather supportive data on the safety and effectiveness of manualized MDMA-assisted therapy as a treatment for PTSD. This was the first study of MDMA-assisted therapy using the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) as a primary outcome measure. This study also served to provide clinical supervision to planned Phase 3 therapy teams. This study was also the first multi-site study of MDMA-assisted therapy for PTSD and explored the reproducibility of findings in a multi-site format to prepare for Phase 3 trials.
“After undergoing three Experimental Sessions of MDMA-assisted therapy, 90.6% of participants reported a clinically significant reduction in CAPS-5 total severity scores and 75% of participants no longer met PTSD diagnostic criteria.”
This study included 33 participants in the analysis. Participants underwent three open-label Experimental Sessions with either 80 mg or 120 mg of MDMA, followed by a supplemental half-dose, administered with manualized therapy. At the Primary Endpoint, the mean change in CAPS-5 total severity score from Baseline was a reduction of 30.5 (SD: 14.1). After one Experimental Session, 63.6% of participants reported a clinically significant reduction in CAPS-5 total severity score and 33.3% of participants no longer met PTSD diagnostic criteria. At the Primary Endpoint, after undergoing three Experimental Sessions of MDMA-assisted therapy, 90.6% of participants reported a clinically significant reduction in CAPS-5 total severity scores and 75% of participants no longer met PTSD diagnostic criteria.
The most frequently occurring adverse events were headaches, muscle tightness, nausea, anxiety, suicidal ideation, fatigue, and nystagmus. No participants had serious suicidal ideation or positive behavior after any of the Experimental Sessions, as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS). Overall, the IMP was well-tolerated by all participants and only transient increases in mean blood pressure and pulse were observed during Experimental Sessions.
- Current Status: Completed
- ClinicalTrials.gov Record
- Study Protocol
- Combined MP16 and MP17 Publication