An Open-Label, Phase 2, Feasibility Study of Manualized MDMA-Assisted Psychotherapy in Subjects with Major Depressive Disorder
Open-label Phase II feasibility study (n=12) of manualized MDMA-assisted psychotherapy for moderate-to-severe MDD, with up to two experimental oral MDMA sessions (supplemental dose allowed) and clinician-rated MADRS change at ~12 weeks as primary outcome.
Details
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.