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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                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200953) or placebo with therapy (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200951). Overall, 26.9% (28\/104) of participants had moderate PTSD, and 73.1% (76\/104) of participants had severe PTSD. Participants were ethnoracially diverse: 28 of 104 (26.9%) identified as Hispanic\/Latino, and 35 of 104 (33.7%) identified as other than White. Least squares (LS) mean change in CAPS-5 score (95% confidence interval (CI)) was \u221223.7 (\u221226.94, \u221220.44) for MDMA-AT versus \u221214.8 (\u221218.28, \u221211.28) for placebo with therapy (\n                    <jats:italic>P<\/jats:italic>\n                    \u2009&lt;\u20090.001,\n                    <jats:italic>d<\/jats:italic>\n                    \u2009=\u20090.7). LS mean change in SDS score (95% CI) was \u22123.3 (\u22124.03, \u22122.60) for MDMA-AT versus \u22122.1 (\u22122.89, \u22121.33) for placebo with therapy (\n                    <jats:italic>P<\/jats:italic>\n                    \u2009=\u20090.03,\n                    <jats:italic>d<\/jats:italic>\n                    \u2009=\u20090.4). Seven participants had a severe treatment emergent adverse event (TEAE) (MDMA-AT,\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20095 (9.4%); placebo with therapy,\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20092 (3.9%)). There were no deaths or serious TEAEs. These data suggest that MDMA-AT reduced PTSD symptoms and functional impairment in a diverse population with moderate to severe PTSD and was generally well tolerated. ClinicalTrials.gov identifier:\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT04077437\">NCT04077437<\/jats:ext-link>\n                    .\n                  <\/jats:p>","DOI":"10.1038\/s41591-023-02565-4","type":"journal-article","created":{"date-parts":[[2023,9,14]],"date-time":"2023-09-14T12:03:52Z","timestamp":1694693032000},"page":"2473-2480","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":440,"title":["MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial"],"prefix":"10.1038","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7567-8129","authenticated-orcid":false,"given":"Jennifer 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M.O.G.: Aguazul-Bluewater, Inc has received research support from MAPS PBC and payments from Cybin (training and consultation), from Horizons Conference and from Naropa University. B.v.d.K. has received royalties from Penguin Random House (book, <i>The Body Keeps the Score<\/i>) and Guilford Press (book, <i>Traumatic Stress<\/i>); has received consulting fees from Meadows Hospital (Wickenburg, Arizona); and has received payment\/honoraria from PESI. B.v.d.K. is also the president of the Trauma Research Foundation. S.S. has received grants\/contracts from MAPS (research support) and MindMed (research support); has received royalties\/licenses from Academic Press and Norton Publishing (professional books); has received honoraria from Scripps, the Integrative Psychiatric Institute and the Institute of Functional Medicine (lectures and presentations); is member of the Maya Health Advisory Board; and previously served as CEO of the Board of Psychedelic Medicine and Therapies. M.B. has received grant support to his institution for the current study from MAPS PBC; has received grants\/contracts to his institution from Mend Medicine, Tilray Canada and the Heffter Research Institute; has been paid by AJNA Labs, Journey Colab and Bright Minds Biosciences for advisory board participation; and has received drug to his institution from Tilray Canada for an NIH-funded trial. Y.G. anticipates support from MAPS PBC for congress attendance in the future and has stock in MindMed. C.P. has received grants\/contracts (research support) and consulting fees from MAPS PBC (training and supervision\/consultation). C.R.N. has received grants\/contracts fromm MAPS PBC (research studies); has received payment\/honoraria from MAPS PBC and MindMed (training and educational events); has received meeting\/travel support from MAPS PBC; and has received funding for contract work as an MDMA-assisted therapy trainer. S.Q. has received grants\/contract support for research from MAPS. B.B. has received support for the present study from New School Research and the California Center for Psychedelic Therapy; has received consulting fees from MAPS PBC (training and supervision\/consultation); has received payment\/honoraria from the Integrative Psychiatric Institute, the California Association of Marriage and Family Therapists, the Los Angeles County Psychological Society and the Palm Springs Art Museum (lectures\/speaking events); has received support for meetings\/travel from MAPS PBC; and is a trainer representative for the MAPS PBC Commercial Advisory Committee and supervisor and coordinator of the Zendo Project (psychedelic harm reduction). S.H. is an employee of MAPS PBC. M.M. has received support for the present research from MAPS PBC (independent contractor) and is a member of the Awakn Life Sciences Scientific Advisory Board; has received royalties from PESI (video sales of presentations); has received consulting fees from MAPS PBC; has received payment from PESI (speaking) and the California Institute of Integral Studies (training workshops); has received honoraria from Harvard Medical School, Sounds True, the Integrative Psychiatry Institute and Vital (speaking); has received support from MAPS PBC for attending meetings\/travel; and owns stock in Awakn Life Sciences. S.K. has received grants\/contracts\/consulting fees from MAPS PBC, pharmaceutical companies, VA hospitals and university research groups for providing supervision and training to psychodiagnostic assessors on a variety of research studies. K.P.-G. has received consulting fees from MAPS PBC for training assessors in psychodiagnostic assessment on PTSD treatment trials and from other research studies\/groups conducting similar work. K.T. has received payment\/honoraria from MAPS US (education and study activities in Israel), MAPS PBC (senior trainer and supervisor therapist) and MAPS Israel (co-founder and CEO) and meeting\/travel support from MAPS PBC. C.H. is a MAPS PBC employee; has received consulting fees from Cybin (unrelated molecule and indication in the psychedelics field); and has received meeting\/travel support from MAPS PBC. A.d.B. was previously an employee of MAPS PBC; has received consulting fees (to Tulip Medical Consulting); has received meeting travel\/support from MAPS PBC; and served as CMO (while previously an employee of MAPS PBC) and attended Data Safety Monitoring Board meetings without any voting rights. R.D. is the founder and president (salaried employee) of MAPS and is a member of the Board of MAPS and MAPS PBC. B.Y.-K. is an employee of MAPS PBC, was previously an employee of MAPS and has received support from MAPS PBC and MAPS for attending meetings\/travel.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}