Evidence map›Paper›PMID 31572236›Full record

ReviewFrontiers in psychiatry2019

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

Allison A Feduccia, Lisa Jerome, Berra Yazar-Klosinski, Amy Emerson, Michael C Mithoefer, Rick Doblin

Registry-linked trialOpen access · goldAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Frontiers in psychiatry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06954025 (High-Intensity Inpatient MDMA-Assisted Psychotherapy for Treatment-Refractory Posttraumatic Stress Disorder), which is not on this map. Cited by 67 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 6 pooled it
16.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06954025 phase2enrolling by invitationnot on this mapstarted 2025, after this paper: background citation

High-Intensity Inpatient MDMA-Assisted Psychotherapy for Treatment-Refractory Posttraumatic Stress Disorder: An Open-Label Pilot Study

TypeinterventionalSponsorARQ National Psychotrauma CentreRan2025 to 2027Enrolled20ConditionsPosttraumatic Stress Disorder (PTSD)ArmsHigh-intensity inpatient MDMA-assisted psychotherapy
3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 6 syntheses or guidelines pooled it, 169 citations in OpenAlex.

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7 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Allison A FeducciaDepartment of Research Development and Regulatory Affairs, MAPS Public Benefit Corporation, Santa Cruz, CA, United States.
Lisa JeromeDepartment of Research Development and Regulatory Affairs, MAPS Public Benefit Corporation, Santa Cruz, CA, United States.
Berra Yazar-KlosinskiMultidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, United States.
Amy EmersonMAPS Public Benefit Corporation, Santa Cruz, CA, United States.
Michael C MithoeferDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States.
Rick DoblinMultidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, United States.
Public Service Electric and Gas (United States) · USMultidisciplinary Association for Psychedelic Studies · USMedical University of South Carolina · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

anxietybreakthrough therapymethylenedioxymethamphetamineparoxetineposttraumatic stress disordersertraline

Identifiers

PMID31572236
PMCPMC6751381
OpenAlexW2968540378

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.