A proof-of-principle, open-label clinical trial will test MDMA-assisted therapy for major depressive disorder. Twelve participants with a DSM-5 diagnosis of MDD will receive a flexible dose of MDMA during two dosing sessions over four weeks, each followed by three integration sessions. The primary outcome is change in depression severity measured by the MADRS scale from baseline to eight weeks after the second session. Secondary outcomes include functional impairment and safety measures such as adverse events and suicidality. The trial aims to inform larger studies and optimize the treatment protocol.
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.