MDMA-Assisted Therapy for PTSD Demonstrates Durable Response in Long-Term Observational Follow-Up Study

Preliminary findings from an observational follow-up study evaluating the long-term safety and efficacy of MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD) show that participants demonstrated a durable response at least 6 months after their final MDMA-assisted therapy session.

The findings were released earlier this month by MAPS Public Benefit Corporation (MAPS PBC).

“PTSD is a chronic condition when insufficiently treated and has historically been addressed through long-term maintenance treatment, which is why it’s important to evaluate whether an acute treatment like MDMA-assisted therapy has an enduring response when used to treat PTSD,” MAPS PBC CEO Amy Emerson said in a news release.

The results of the study are consistent with previously published Phase 2 data demonstrating a sustained effect of MDMA-assisted therapy of at least 1 year following treatment, Emerson said, adding that the findings suggest the acute treatment effect could last even longer.

MAPS PBC announced in January that in a pair of Phase 3 studies, participants who received MDMA-assisted therapy showed significant improvement over therapy with placebo when measured at 2 months after their last session. The primary objective of the study published this month was to evaluate long-term effectiveness of MDMA-assisted therapy for the treatment of PTSD as measured by the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score.

Preliminary interim findings show participants in the study demonstrated durable improvements in PTSD according to CAPS-5 total severity scores at least 6 months after their final dosing session. Furthermore, effects of the treatment were found to be maintained in participants who were followed up within a year, as well as those who were followed up more than a year later. The observational follow-up study also found a low rate of relapse following treatment response or loss of PTSD diagnoses, as well as an even lower incidence of relapse following remission.

Follow-up data continues to be collected from study participants, MAPS PBC said.

References

MAPS PBC announces positive topline results from long-term observational follow-up study on MDMA-assisted therapy for treatment of PTSD. News release. MAPS PBC. April 5, 2023. Accessed April 24, 2023.

Valentino T. MDMA-assisted therapy for PTSD delivers positive results in MAPS PBC study. Psych Congress Network. Published online January 9, 2023. Accessed April 24, 2023.