MDMA-assisted therapy is safe and effective for the treatment of people with severe post-traumatic stress disorder (PTSD), according to a phase 3 clinical trial published in Nature Medicine. This study was granted an FDA Breakthrough Therapy designation and provides a new treatment option for people who suffer from PTSD.

Selective serotonin-reuptake inhibitors are the FDA-approved first-line therapeutics for the treatment of PTSD, but nearly half of patients do not respond to these drugs. The substituted amphetamine MDMA also targets the serotonin system and has shown promise in animal and early clinical studies as a treatment for PTSD.

Jennifer Mitchell and colleagues conducted a phase 3 randomized clinical trial during which MDMA was administered to 90 participants, in conjunction with manualized therapy, over the course of 18 weeks. The authors found that MDMA was well tolerated in patients with severe PTSD, and observed a significant and robust reduction in symptoms relative to those of patients receiving a placebo combined with a similar therapy. This treatment approach was also effective in patients with associated comorbidities, such as childhood trauma, dissociation and depression.

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