PMID- 31572236
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 1664-0640 (Print)
IS  - 1664-0640 (Electronic)
IS  - 1664-0640 (Linking)
VI  - 10
DP  - 2019
TI  - Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted 
      Psychotherapy Compared to Paroxetine and Sertraline.
PG  - 650
LID - 10.3389/fpsyt.2019.00650 [doi]
LID - 650
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. Clinical Trial Registration: www.ClinicalTrials.gov, 
      identifiers NCT00090064, NCT00353938, NCT01958593, NCT01211405, NCT01689740, 
      NCT01793610.
CI  - Copyright (c) 2019 Feduccia, Jerome, Yazar-Klosinski, Emerson, Mithoefer and 
      Doblin.
FAU - Feduccia, Allison A
AU  - Feduccia AA
AD  - Department of Research Development and Regulatory Affairs, MAPS Public Benefit 
      Corporation, Santa Cruz, CA, United States.
FAU - Jerome, Lisa
AU  - Jerome L
AD  - Department of Research Development and Regulatory Affairs, MAPS Public Benefit 
      Corporation, Santa Cruz, CA, United States.
FAU - Yazar-Klosinski, Berra
AU  - Yazar-Klosinski B
AD  - Multidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, United 
      States.
FAU - Emerson, Amy
AU  - Emerson A
AD  - MAPS Public Benefit Corporation, Santa Cruz, CA, United States.
FAU - Mithoefer, Michael C
AU  - Mithoefer MC
AD  - Department of Psychiatry and Behavioral Sciences, Medical University of South 
      Carolina, Charleston, SC, United States.
FAU - Doblin, Rick
AU  - Doblin R
AD  - Multidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, United 
      States.
LA  - eng
SI  - ClinicalTrials.gov/NCT01211405
SI  - ClinicalTrials.gov/NCT01958593
SI  - ClinicalTrials.gov/NCT01793610
SI  - ClinicalTrials.gov/NCT00353938
SI  - ClinicalTrials.gov/NCT01689740
SI  - ClinicalTrials.gov/NCT00090064
PT  - Journal Article
PT  - Review
DEP - 20190912
PL  - Switzerland
TA  - Front Psychiatry
JT  - Frontiers in psychiatry
JID - 101545006
PMC - PMC6751381
OTO - NOTNLM
OT  - anxiety
OT  - breakthrough therapy
OT  - methylenedioxymethamphetamine
OT  - paroxetine
OT  - posttraumatic stress disorder
OT  - sertraline
EDAT- 2019/10/02 06:00
MHDA- 2019/10/02 06:01
PMCR- 2019/09/12
CRDT- 2019/10/02 06:00
PHST- 2019/06/26 00:00 [received]
PHST- 2019/08/13 00:00 [accepted]
PHST- 2019/10/02 06:00 [entrez]
PHST- 2019/10/02 06:00 [pubmed]
PHST- 2019/10/02 06:01 [medline]
PHST- 2019/09/12 00:00 [pmc-release]
AID - 10.3389/fpsyt.2019.00650 [doi]
PST - epublish
SO  - Front Psychiatry. 2019 Sep 12;10:650. doi: 10.3389/fpsyt.2019.00650. eCollection 
      2019.