An Open-Label, Phase 2, Feasibility Study of Manualized MDMA-Assisted Psychotherapy in Subjects with Major Depressive Disorder

The primary objective is to evaluate the effect of MDMA-assisted psychotherapy for MDD in clinician-rated depression scores, as measured by the mean change in MADRS scores from Visit 4 (Baseline) to Visit 13 (approximately 12 weeks post Baseline).

The study protocol has been published in October 2022.

Topic Depression

Compound MDMA

Country Norway

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Trial Details

Trial Number

Sponsors & Collaborators

MAPS PBC
MAPS Public Benefit Corporation (MAPS PBC) is the 'benefit above profit' corporation that is fully owned by MAPS.

Papers

MDMA-assisted therapy as a treatment for major depressive disorder: proof of principle study
This open-label pilot study (n=12) found that MDMA-assisted therapy (80-120mg; 2x) significantly reduced depression scores (MADRS) by 19.3 points and functional impairment (-11.7) in participants with moderate to severe major depressive disorder (MDD), with no serious adverse events reported over 8 weeks following treatment.

Measures Used

Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Data attribution

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