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).

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Topic Depression
Compound MDMA
Status Recruiting
Chance of happening 89%
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 12
Sex All
Age 18- 99
Therapy Yes

Trial Details

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 secondary objective of this study is to measure the feasibility of MDMA-assisted psychotherapy for the treatment of MDD, as measured by the Subjective Effects scale (SE). Subjective effects on 15 items (negative mood, body perception changes, confusion, difficulty concentrating, compassion for self, compassion for others, euphoria, positive mood, intellectual efficiency, social, calmness, talkative, open to new experiences, meaningful experience, emotional distress) will be collected using a Visual Analog Scale (VAS) at three time points: initial dose of MDMA, prior to the supplemental dose of MDMA and at the end of the experimental session. The subjective effects chosen for the scales are based on literature reviews of the subjective effects of MDMA among healthy volunteers in controlled studies. The study is considered feasible if there is observed a significant mean change in overall SE from initial dose of MDMA to prior to supplemental dose.

NCT Number

Sponsors & Collaborators

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

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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