Media release

From: Springer Nature

Medical research: MDMA-assisted therapy shown to be effective in diverse group of people

MDMA-assisted therapy reduces symptoms and functional impairment in ethnically and racially diverse people with moderate to severe post-traumatic stress disorder (PTSD), a phase 3 trial published in Nature Medicine suggests. The findings, which relate to individuals often under-represented in clinical trials, confirm and extend the findings of a previous phase 3 trial demonstrating the safety and therapeutic potential of the therapy.

A previous phase 3 trial from Jennifer Mitchell and colleagues showed that MDMA-assisted therapy was well tolerated and met the trial’s primary and secondary endpoints of reduced PTSD symptom severity and decreased functional impairment in people with severe PTSD. However, it was unclear if these findings could be generalized to populations with moderate PTSD symptoms or people with disproportionately higher risk of developing PTSD. Due to disparities in trauma exposure, ethnic and racial minorities, alongside gender-diverse and transgender people, first responders, military personnel, veterans, and victims of chronic sexual abuse, have a disproportionately higher risk of developing PTSD.

Jennifer Mitchell and colleagues have now conducted a randomized phase 3 clinical trial assessing the efficacy and safety of MDMA-assisted therapy versus therapy with placebo (as a control) administered for 18 weeks to 104 participants diagnosed with moderate to severe PTSD. Participants in the trial were ethnically and racially diverse, with 34% of participants identifying their race as other than white and 27% identifying as Hispanic and/or Latino. The authors report that that MDMA-assisted therapy reduced PTSD symptoms relative to therapy with placebo. They indicate that by end of the study, 71.2% participants in the MDMA-assisted therapy group no longer met the diagnostic criteria for PTSD, versus 47.6% participants in the therapy-with-placebo group. They note that MDMA-assisted therapy was well tolerated, with no deaths or serious adverse events identified.

The authors conclude that their findings confirm and extend the results observed in their previous trial, suggesting MDMA-assisted therapy may be effective as a treatment for a broader population of people with PTSD.