MDMA-Assisted Therapy Shows Safety and Efficacy for PTSD Treatment

3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy is shown to be safe and efficacious in the treatment of severe post-traumatic stress disorder (PTSD), according to study results published in Nature Medicine.

“The selective serotonin reuptake inhibitors (SSRIs) sertraline and paroxetine are Food and Drug Administration (FDA)-approved first-line therapeutics for the treatment of PTSD. However, an estimated 40%-60% of patients do not respond to these compounds,” writes lead researcher Jennifer M. Mitchell, Department of Psychiatry and Behavioral Sciences, University of California San Francisco.

The phase 3, randomized, double-blind, placebo-controlled clinical trial comprised 91 patients who did not respond to traditional psychiatric medication therapies to treat their PTSD. Of participants, 46 were randomized to MDMA therapy and 44 to the placebo treatment. Both groups also had 3 preparatory and 9 integrative psychotherapy sessions combined with the medication.

PTSD symptoms were measured using the Clinical Administration PTSD Scale for DSM-5 (CAPS-5), and functional impairment was assessed using the Sheehan Disability Scale (SDS). Mitchell et al report that, “MDMA was found to induce significant and robust attenuation in CAPS-5 score compared with placebo (P < 0.0001, d = 0.91) and to significantly decrease the SDS total score (P = 0.0116, d = 0.43). The mean change in CAPS-5 scores in participants completing treatment was −24.4 (SD 11.6) in the MDMA group and −13.9 (SD 11.5) in the placebo group.”

At study endpoint, 67% of participants in the MDMA group no longer met the diagnostic criteria for PTSD compared with 32% of placebo-group participants after 3 sessions. The criteria for remission were met in 33% of MDMA participants compared with only 5% of the placebo group after 3 sessions. Of note, researchers found no major safety issues with the use of MDMA combined with psychotherapy for the treatment of PTSD.

Mitchell et al conclude by stating, “MDMA-assisted therapy induces rapid onset of treatment efficacy, even in those with severe PTSD, and in those with associated comorbidities including dissociative PTSD, depression, history of alcohol and substance use disorders, and childhood trauma. Not only is MDMA-assisted therapy efficacious in individuals with severe PTSD, but it may also provide improved patient safety.”

Reference

Mitchell JM, Bogenschutz M, Lilienstein A, et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021;27:1025-1033.