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

ABSTRACT:

Background

3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy (MDMA-AT) has shown promising safety and efficacy in phase 3 studies of post-traumatic stress disorder, but has not been investigated for a primary diagnosis of major depressive disorder (MDD).

Aim

We aimed to explore the proof of principle and safety as a first study with MDMA-AT for MDD, and to provide preliminary efficacy data.

Method

Twelve participants (7 women, 5 men) with moderate to severe MDD received MDMA in 2 open-label sessions 1 month apart, along with psychotherapy before, during and after the MDMA sessions, between January 2023 and May 2024. The primary outcome measure was mean change in Montgomery-Asberg Depression Rating Scale (MADRS), and the secondary outcome measure was mean chang

SUBMITTER: Kvam TM 

PROVIDER: S-EPMC12550655 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature