articleNature MedicineSep 14, 2023HYBRID OA

MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial

JMJennifer MitchellMOMarcela Ot’alora G.BVBessel van der KolkSSScott ShannonMPMichael P. Bogenschutz

San Francisco VA Medical Center · University of California, San Francisco · +10 more institutions

PubMed
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Abstract

This multi-site, randomized, double-blind, confirmatory phase 3 study evaluated the efficacy and safety of 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) versus placebo with identical therapy in participants with moderate to severe post-traumatic stress disorder (PTSD). Changes in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score (primary endpoint) and Sheehan Disability Scale (SDS) functional impairment score (key secondary endpoint) were assessed by blinded independent assessors. Participants were randomized to MDMA-AT (n = 53) or placebo with therapy (n = 51). Overall, 26.9% (28/104) of participants had moderate PTSD, and 73.1% (76/104) of participants had severe PTSD.…

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Topics & keywords

Topics
Keywords
  • MDMA
  • Placebo
  • Randomized controlled trial
  • Medicine
  • Psychiatry
  • Internal medicine
  • Alternative medicine
  • Pathology
UN Sustainable Development Goals
  • Good health and well-being
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