{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T20:49:36Z","timestamp":1793047776154,"version":"4.5.0"},"reference-count":36,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T00:00:00Z","timestamp":1785974400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T00:00:00Z","timestamp":1785974400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100000272","name":"DH | National Institute for Health Research","doi-asserted-by":"publisher","award":["CS-2017-17-007"],"award-info":[{"award-number":["CS-2017-17-007"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Nat Med"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Psilocybin-assisted therapy may be a promising new treatment for treatment-resistant depression. We examined the feasibility of administering a single 25-mg dose of psilocybin or placebo with psychological support in a randomized controlled trial design with 6\u2009weeks of follow-up. A two-arm, double-blind, randomized, placebo-controlled feasibility trial was conducted at one National Health Service (NHS) site in England. Eligible participants met\n                    <jats:italic>Diagnostic and Statistical Manual of Mental Disorders<\/jats:italic>\n                    , Fifth Edition (DSM-5) criteria for major depressive disorder and had an inadequate response to \u22652 antidepressant treatments or \u22651 antidepressant plus \u22651 psychotherapy. Participants received 25-mg psilocybin or placebo with preparation, dosing support and integration. Primary outcomes were recruitment, retention and estimation of the Montgomery\u2212\u00c5sberg Depression Rating Scale (MADRS) variance. A multilevel regression analysis with an intention-to-treat population was used. Sixty participants were randomized (1:1), balanced by age, sex and prior psilocybin exposure, and 59 of 60 participants completed the MADRS at all follow-up visits. The adjusted between-group difference at week 3 on the MADRS was \u221210.41 (95% confidence interval: \u221214.86 to \u22125.95; Cohen\u2019s\n                    <jats:italic>d<\/jats:italic>\n                    \u2009=\u2009\u22121.70), favoring psilocybin, which was sustained at week 6. In total, 123 and 164 nonserious adverse events occurred in the placebo and psilocybin arms, respectively. Findings support a future confirmatory trial. EudraCT no.:\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/www.clinicaltrialsregister.eu\/ctr-search\/search?query=2018-003573-97\" ext-link-type=\"uri\">2018-003573-97<\/jats:ext-link>\n                    .\n                  <\/jats:p>","DOI":"10.1038\/s41591-026-04541-0","type":"journal-article","created":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T09:02:15Z","timestamp":1786006935000},"page":"3430-3437","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Psilocybin-assisted therapy for treatment-resistant major depressive disorder in a public healthcare setting: a randomized controlled trial"],"prefix":"10.1038","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4647-8088","authenticated-orcid":false,"given":"James 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J.R. has also been awarded grant funding (received and managed by King\u2019s College London) from COMPASS Pathways, Beckley PsyTech, the Multidisciplinary Association for Psychedelic Studies, Transcend Therapeutics, MindMed, Cybin, the National Institute for Health and Care Research (NIHR), the Wellcome Trust and the Biomedical Research Centre at the South London and Maudsley NHS Foundation Trust. J.K.-G. has received grants from the Psychiatry Research Trust and owns shares in GlaxoSmithKline and AstraZeneca. N.L.M. is currently an employee of subsidiaries of COMPASS Pathways plc; however, he was not employed by COMPASS Pathways plc at the time this study was conducted. COMPASS Pathways plc did not contribute to the content or the views expressed in this publication and did not provide financial support for its preparation. N.L.M.\u2019s contributions to this publication were made while he was employed by King\u2019s College London and outside of any employment relationship with COMPASS Pathways plc. N.L.M. has also received consultancy fees from Sunstone Therapies. L.A.J. has received grants from the Medical Research Council (MRC). R.R.-Z. received funding from the NIHR, is employed by King\u2019s College London and the South London and Maudsley NHS Trust, has received consulting fees from Mindset Technologies Ltd., received support for conference attendance from the MRC-NIHR Trials Methodology Research Partnership and owns stock in Mindset Technologies Ltd. M.S. is an employee of AtaiBeckley and owns stock in AtaiBeckley. A.H.Y. is Editor of the\n                      Journal of Psychopharmacology\n                      and Deputy Editor of\n                      BJPsych Open\n                      . A.H.Y. has given paid lectures and has served on advisory boards for the following companies with drugs used in affective and related disorders: AstraZeneca, Boehringer Ingelheim, Eli Lilly, LivaNova, Lundbeck, Sunovion, Servier, Janssen, Allegan, Bionomics, Sumitomo Dainippon Pharma, COMPASS Pathfinder Ltd. (a subsidiary of COMPASS Pathways plc), Sage, Novartis and Neurocentrx. A.H.Y. is principal investigator on the following studies: Restore-Life VNS registry study, funded by LivaNova; ESKETINTRD3004: \u2018An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression\u2019; \u2018The Effects of Psilocybin on Cognitive Function in Healthy Participants\u2019; and \u2018The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (P-TRD)\u2019. A.H.Y. is UK Chief Investigator for COMPASS, COMP006 and COMP007 studies and UK Chief Investigator for Novartis MDD study MIJ821A12201. A.H.Y. has also received grant funding (past and present) from the following: National Institute of Mental Health (USA); Canadian Institutes of Health Research (Canada); National Alliance for Research on Schizophrenia and Depression (USA); Stanley Medical Research Institute (USA); MRC (UK); Wellcome Trust (UK); Royal College of Physicians of Edinburgh; British Medical Association (UK); VGH & UBS Hospital Foundation (Canada); WEDC (Western Economic Diversification Canada) (Canada); CCS Depression Research Fund (Canada); MSFHR (Michael Smith Foundation for Health Research) (Canada); NIHR (UK); and Janssen (UK) EU Horizon 2020. T.M., C.B., P.C., K.C.-C., S.H., P.S., R.H., D.F., E.H., D.T., R.J.T., J.C., H.J., C.D., M.B., A.B., M.L., T.B.-P., L.B., F.A., M.C. and B.C. declare no competing interests.","order":1,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Ethics"}}]}}