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

ABSTRACT:

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

SUBMITTER: Kvam TM 

PROVIDER: S-EPMC9645093 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature