This open-label Phase II feasibility study (n=12) of manualized MDMA-assisted psychotherapy for moderate-to-severe depression (MDD) included up to two experimental oral MDMA sessions (supplemental dose allowed) and used clinician-rated MADRS change at ~12 weeks as the primary outcome.
Open-label, single-site Phase 2 feasibility trial in Norway testing manualized MDMA-assisted psychotherapy in adults with current major depressive disorder (MADRS ≥20). Twelve participants receive preparatory psychotherapy, up to two experimental oral MDMA sessions (with a possible supplemental dose), and integration sessions.
Primary endpoint is change in MADRS from baseline to approximately 12 weeks; secondary outcomes assess feasibility and subjective effects using a 15-item Visual Analogue Scale at baseline, prior to supplemental dose, and at session end. Safety procedures include medical screening, overnight observation and exclusion of participants at significant suicide risk.
Open-label manualized MDMA-assisted psychotherapy with up to two experimental sessions and possible supplemental dose.
MDMA HCl capsules per protocol; psychotherapy provided during sessions. Initial 80 mg MDMA dose with supplemental 40 mg allowed; represented as doseMax 120 mg.
This long-term follow-up (n=12) of participants with moderate-to-severe major depressive disorder who received MDMA-assisted therapy (two dosing sessions integrated with nine psychotherapy sessions) found significant reductions in depression severity and functional impairment at seven months compared to baseline, with improvements maintained from the post-treatment assessment and no increases in suicidal ideation.