In an open-label study of twelve adults with moderate to severe major depressive disorder, two sessions of MDMA-assisted therapy one month apart, combined with psychotherapy, led to a substantial average reduction of 19.3 points on the Montgomery-Asberg Depression Rating Scale and an average decrease of 11.7 points on the Sheehan Disability Scale, indicating improved daily functioning. No serious or unexpected adverse events occurred. The results suggest the approach is safe and feasible, with strong indications of efficacy, though randomized controlled trials are needed to confirm.
In a small long-term follow-up of twelve people with major depressive disorder, MDMA-assisted therapy—two MDMA dosing sessions combined with nine psychotherapy sessions—led to sustained reductions in depression severity and disability seven months after baseline. Depression scores on the Montgomery-Asberg Depression Rating Scale and disability scores on the Sheehan Disability Scale remained significantly lower than before treatment, with no significant changes from the immediate post-treatment visit. Suicidal ideation did not exceed pre-study levels. The results suggest lasting treatment effects and safety, though the authors call for larger controlled trials to confirm these preliminary findings.