Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline
Abstract
Unsuccessfully treated posttraumatic stress disorder (PTSD) is a serious and life-threatening disorder. Two medications, paroxetine hydrochloride and sertraline hydrochloride, are approved treatments for PTSD by the Food and Drug Administration (FDA). Analyses of pharmacotherapies for PTSD found only small to moderate effects when compared with placebo. The Multidisciplinary Association for Psychedelic Studies (MAPS) obtained Breakthrough Therapy Designation (BTD) from the FDA for 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for treatment of PTSD on the basis of pooled analyses showing a large effect size for this treatment. This review covers data supporting BTD. In this treatment, MDMA is administered with psychotherapy in up to three monthly 8-h sessions. Participants are prepared for these sessions beforehand, and process material arising from the sessions in follow-up integrative psychotherapy sessions. Comparing data used for the approval of paroxetine and sertraline and pooled data from Phase 2 studies, MAPS demonstrated that MDMA-assisted psychotherapy constitutes a substantial improvement over available pharmacotherapies in terms of safety and efficacy. Studies of MDMA-assisted psychotherapy had lower dropout rates compared to sertraline and paroxetine trials. As MDMA is only administered under direct observation during a limited number of sessions, there is little chance of diversion, accidental or intentional overdose, or withdrawal symptoms upon discontinuation. BTD status has expedited the development of MAPS phase 3 trials occurring worldwide, leading up to a planned submission seeking FDA approval in 2021.
Appeared originally in Front Psychiatry 2019; 10:650
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Published in print: Summer 2023
Published online: 14 July 2023
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Conflict of Interest Statement: AF received salary support for full time employment with MAPS PBC. LJ received salary support for full time employment with MAPS PBC. BY-K received salary support for full time employment with MAPS. AE received salary support for full time employment with MAPS PBC. MM received salary support from MAPS PBC as a clinical investigator and clinical trial medical monitor as well as for training and supervision of research psychotherapists. RD received salary support for full time employment with MAPS.
The Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c) (3) nonprofit organization, provided the MDMA and fully funded this study. MAPS Public Benefit Corporation (MAPS PBC), a wholly owned subsidiary of MAPS, was the trial organizer. MAPS and MAPS PBC assisted with study design; monitoring of study data; analysis, management, and interpretation of data; preparation, review, and approval of manuscript; and decision to submit the manuscript for publication. The funder had no role in the collection of data or conduct of the study.
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Edited by: Felix Müller, University Psychiatric Clinic Basel, Switzerland
Reviewed by: Tomislav Majic, Charité–Universitätsmedizin Berlin, Germany; Katrin H. Preller, University of Zurich, Switzerland
Specialty section: This article was submitted to Psychopharmacology, a section of the journal Frontiers in Psychiatry
Author Contributions: Concept and review design: LJ, AF, AE, BY-K, RD, and MM. Acquisition, analysis, or interpretation of data: LJ, AF, AE, BY-K, RD, and MM. Drafting of the manuscript: LJ, AF, AE, BY-K, RD, and MM. Critical revision of the manuscript for important intellectual content: LJ, AF, AE, BY-K, RD, and MM. Obtained funding: RD.
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