In November 2020, MAPS Public Benefit Corporation (MAPS PBC) completed data analysis of the first of two Phase 3 trials of MDMA-assisted therapy for treatment of posttraumatic stress disorder (PTSD). The results confirmed Phase 2 results and prior expectations from an independent interim analysis which determined there was a 90% or greater probability that the trial, when completed, would be of sufficient size to detect statistically significant results. Further, no unexpected or serious safety signals emerged during the course of the trial.
The results indicate MDMA-assisted therapy for PTSD may be an effective treatment for PTSD resulting from various types of trauma, including trauma occurring in childhood and in patients with dissociative subtype of PTSD, pending assessment by the U.S. Food and Drug Administration (FDA). Based on these results, MAPS will begin discussions with the FDA on ways to accelerate the timeframe for approval of this modality.
The Phase 3 trial, the first of its kind in scope and size, treated 90 participants who received 3 day-long MDMA or placebo sessions one month apart and 12 90-minute non-drug therapy sessions over approximately 3.5 months. The severity of PTSD symptoms was measured using the Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5); measurements were taken before and after completion of treatment. Of these 90 participants, approximately half received MDMA-assisted therapy. The other half of participants, the control group, received placebo with identical therapy. A second Phase 3 clinical trial is currently enrolling participants.
Bessel van der Kolk, M.D., a leading PTSD researcher and author of the foundational book on PTSD, The Body Keeps the Score, served as Principal Investigator for the Boston site of the study. He noted, "The experience of having been traumatized profoundly alters perceptions; self-experience; and capacity to plan, imagine and anticipate. Since the results of this study mirror previously published results, we can expect to see fundamental shifts in our subjects' perspective on self-capacity, affect regulation, and attitude towards those around them. It takes a great deal of courage to address one’s PTSD, particularly when other treatments have failed. These results open the door to a powerful new pathway to healing once MDMA-assisted psychotherapy has been approved as a treatment for PTSD."