Study protocol for "MDMA-assisted therapy as a treatment for major depressive disorder: A proof of principle study".

Background

Major depressive disorder (MDD) is a world-leading cause of disability. The available treatments are not effective in all patients, and there is a significant need for more effective treatment options. Here we present the protocol for an investigator-initiated and publicly funded trial of MDMA-assisted therapy (MDMA-AT) for MDD. This single-site, open-label study investigates the proof of principle and safety of MDMA-AT in participants with MDD and provides an initial impression of treatment effectiveness.

Methods

A total of 12 participants [>18 years] with DSM-5 diagnosis of MDD will receive a flexible dose of MDMA in a therapeutic setting on two dosing days over a 4 week period preceded by three preparatory sessions. Each MDMA dosing session will be followed by three integration sessions. The primary outcome is change in MDD symptom severity, as measured by the mean change in MADRS scores from Baseline to 8 weeks after the second MDMA session. The secondary outcome is change in functional impairment, as evaluated by the mean change in Sheehan Disability Scale scores from Baseline to 8 weeks after the second MDMA session. Safety measures include vital signs, the incidence of Adverse Events and suicidality as measured by the Colombia-Suicide Severity Rating Scale.

Discussion

This proof of principle trial will inform the development of fully powered clinical trials, optimize the protocol for the administration of MDMA-AT in participants with MDD and explore uncertainties including barriers to recruitment, retention and acceptability of MDMA-AT as a treatment for MDD.

Clinical trial identification

EudraCT number 2021-000805-26.

Informations de copyright

Copyright © 2022 Kvam, Goksøyr, Stewart, Repantis, Røssberg and Andreassen.

Déclaration de conflit d'intérêts

Author T-MK received lecture honorarium from Lundbeck. Author LS was employed by Awakn Life Sciences Inc. Author OA was a consultant for HealthLytix and has received speaker honorarium from Lundbeck and Sunovion. Author IG was an advisor for Solrise Life Sciences. Several authors are employed at institutions T-MK, IG, LS, and OA at Østfold Hospital; DR at the Charité, which have received research support from MAPS for an MDMA-AT trial for PTSD. Author DR is founding member and honorary Board Chair of MAPS Deutschland, a Germany-based non-profit research and educational organization associated with MAPS. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.