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
Visit trial
Status
Recruiting
Results Published
No
Start date
19 November 2021
End date
12 December 2023
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 PBCMAPS Public Benefit Corporation (MAPS PBC) is the 'benefit above profit' corporation that is fully owned by MAPS.
Measures Used
Montgomery-Asberg Depression Rating ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.