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Review
. 2019 Sep 12:10:650.
doi: 10.3389/fpsyt.2019.00650. eCollection 2019.

Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline

Allison A Feduccia  1 , Lisa Jerome  1 , Berra Yazar-Klosinski  2 , Amy Emerson  3 , Michael C Mithoefer  4 , Rick Doblin  2
Affiliations
Review

Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline

Allison A Feduccia et al. Front Psychiatry. .

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. Clinical Trial Registration: www.ClinicalTrials.gov, identifiers NCT00090064, NCT00353938, NCT01958593, NCT01211405, NCT01689740, NCT01793610.

Keywords: anxiety; breakthrough therapy; methylenedioxymethamphetamine; paroxetine; posttraumatic stress disorder; sertraline.

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References

    1. Food and Drug Administration Guidance for industry; expedited programs for serious conditions — drugs and biologics. Silver Spring, MD: US Dept. of Health and Human Services; (2014).
    1. Food and Drug Administration CDER breakthrough therapy designation requests received by fiscal year. (2018). https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsa...”. Food and Drug Administration).
    1. Haviland MG, Banta JE, Sonne JL, Przekop P. Posttraumatic stress disorder-related hospitalizations in the United States (2002–2011): rates, co-occurring illnesses, suicidal ideation/self-harm, and hospital charges. J Nerv Ment Dis (2016) 204:78–86. 10.1097/NMD.0000000000000432 - DOI - PubMed
    1. Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry (2005) 62:593–602. 10.1001/archpsyc.62.6.593 - DOI - PubMed
    1. Hoge CW, Castro CA, Messer SC, Mcgurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med (2004) 351:13–22. 10.1056/NEJMoa040603 - DOI - PubMed

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