PMID- 37404974
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230718
IS  - 1541-4094 (Print)
IS  - 1541-4108 (Electronic)
IS  - 1541-4094 (Linking)
VI  - 21
IP  - 3
DP  - 2023 Jul
TI  - Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted 
      Psychotherapy Compared to Paroxetine and Sertraline.
PG  - 306-314
LID - 10.1176/appi.focus.23021013 [doi]
AB  - 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.
CI  - Copyright (c) 2023 by the American Psychiatric Association.
FAU - Feduccia, Allison A
AU  - Feduccia AA
AD  - Department of Research Development and Regulatory Affairs, MAPS Public Benefit 
      Corporation, Santa Cruz, CA, United States (Feduccia, Jerome). Multidisciplinary 
      Association for Psychedelic Studies, Santa Cruz, CA, United States 
      (Yazar-Klosinski, Doblin). MAPS Public Benefit Corporation, Santa Cruz, CA, 
      United States (Emerson). Department of Psychiatry and Behavioral Sciences, 
      Medical University of South Carolina, Charleston, SC, United States (Mithoefer).
FAU - Jerome, Lisa
AU  - Jerome L
AD  - Department of Research Development and Regulatory Affairs, MAPS Public Benefit 
      Corporation, Santa Cruz, CA, United States (Feduccia, Jerome). Multidisciplinary 
      Association for Psychedelic Studies, Santa Cruz, CA, United States 
      (Yazar-Klosinski, Doblin). MAPS Public Benefit Corporation, Santa Cruz, CA, 
      United States (Emerson). Department of Psychiatry and Behavioral Sciences, 
      Medical University of South Carolina, Charleston, SC, United States (Mithoefer).
FAU - Yazar-Klosinski, Berra
AU  - Yazar-Klosinski B
AD  - Department of Research Development and Regulatory Affairs, MAPS Public Benefit 
      Corporation, Santa Cruz, CA, United States (Feduccia, Jerome). Multidisciplinary 
      Association for Psychedelic Studies, Santa Cruz, CA, United States 
      (Yazar-Klosinski, Doblin). MAPS Public Benefit Corporation, Santa Cruz, CA, 
      United States (Emerson). Department of Psychiatry and Behavioral Sciences, 
      Medical University of South Carolina, Charleston, SC, United States (Mithoefer).
FAU - Emerson, Amy
AU  - Emerson A
AD  - Department of Research Development and Regulatory Affairs, MAPS Public Benefit 
      Corporation, Santa Cruz, CA, United States (Feduccia, Jerome). Multidisciplinary 
      Association for Psychedelic Studies, Santa Cruz, CA, United States 
      (Yazar-Klosinski, Doblin). MAPS Public Benefit Corporation, Santa Cruz, CA, 
      United States (Emerson). Department of Psychiatry and Behavioral Sciences, 
      Medical University of South Carolina, Charleston, SC, United States (Mithoefer).
FAU - Mithoefer, Michael C
AU  - Mithoefer MC
AD  - Department of Research Development and Regulatory Affairs, MAPS Public Benefit 
      Corporation, Santa Cruz, CA, United States (Feduccia, Jerome). Multidisciplinary 
      Association for Psychedelic Studies, Santa Cruz, CA, United States 
      (Yazar-Klosinski, Doblin). MAPS Public Benefit Corporation, Santa Cruz, CA, 
      United States (Emerson). Department of Psychiatry and Behavioral Sciences, 
      Medical University of South Carolina, Charleston, SC, United States (Mithoefer).
FAU - Doblin, Rick
AU  - Doblin R
AD  - Department of Research Development and Regulatory Affairs, MAPS Public Benefit 
      Corporation, Santa Cruz, CA, United States (Feduccia, Jerome). Multidisciplinary 
      Association for Psychedelic Studies, Santa Cruz, CA, United States 
      (Yazar-Klosinski, Doblin). MAPS Public Benefit Corporation, Santa Cruz, CA, 
      United States (Emerson). Department of Psychiatry and Behavioral Sciences, 
      Medical University of South Carolina, Charleston, SC, United States (Mithoefer).
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20230628
PL  - United States
TA  - Focus (Am Psychiatr Publ)
JT  - Focus (American Psychiatric Publishing)
JID - 101156081
PMC - PMC10316208
OTO - NOTNLM
OT  - anxiety
OT  - breakthrough therapy
OT  - methylenedioxymethamphetamine
OT  - paroxetine
OT  - posttraumatic stress disorder
OT  - sertraline
EDAT- 2023/07/05 13:05
MHDA- 2023/07/05 13:06
PMCR- 2024/07/01
CRDT- 2023/07/05 10:45
PHST- 2024/07/01 00:00 [pmc-release]
PHST- 2023/07/05 13:06 [medline]
PHST- 2023/07/05 13:05 [pubmed]
PHST- 2023/07/05 10:45 [entrez]
AID - FOC_23021013 [pii]
AID - 10.1176/appi.focus.23021013 [doi]
PST - ppublish
SO  - Focus (Am Psychiatr Publ). 2023 Jul;21(3):306-314. doi: 
      10.1176/appi.focus.23021013. Epub 2023 Jun 28.