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Withdrawal from serotonergic antidepressant drugs is a common prerequisite for taking part in trials of psilocybin due to the possibility of ongoing antidepressant drugs altering the psychedelic effect. This phase II, exploratory, international, fixed-dose, open-label study explored the safety, tolerability, and efficacy of a synthetic form of psilocybin (investigational drug COMP360) adjunct to a selective serotonin reuptake inhibitor in participants with TRD. Participants received a single 25 mg dose of psilocybin alongside psychological support and were followed-up for 3 weeks. The primary efficacy end point was change in the Montgomery-\u00c5sberg Depression Rating Scale (MADRS) total score from Baseline at Week 3. Secondary end points were safety, including treatment-emergent adverse events (TEAEs), the proportion of responders and remitters at Week 3, and the change from Baseline to Week 3 in Clinical Global Impression\u2013Severity (CGI-S) score. Nineteen participants were dosed and the mean Baseline MADRS total score was 31.7 (SD\u2009=\u20095.77). Twelve (63.2%) participants had a TEAE, most of which were mild and resolved on the day of onset. There were no serious TEAEs or indication of increased suicidal ideation or behavior. At Week 3, mean change from Baseline in MADRS total score was \u221214.9 (95% CI, \u221220.7 to \u22129.2), and \u22121.3 (SD\u2009=\u20091.29) in the CGI-S. Both response and remission were evident in 8 (42.1%) participants. Larger, comparator-controlled trials are necessary to understand if this paradigm can optimize treatment-outcome where antidepressant drug withdrawal would be problematic.<\/jats:p>","DOI":"10.1038\/s41386-023-01648-7","type":"journal-article","created":{"date-parts":[[2023,7,13]],"date-time":"2023-07-13T09:02:17Z","timestamp":1689238937000},"page":"1492-1499","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":161,"title":["Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication"],"prefix":"10.1038","volume":"48","author":[{"given":"Guy M.","family":"Goodwin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan","family":"Croal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Feifel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John R.","family":"Kelly","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5818-2199","authenticated-orcid":false,"given":"Lindsey","family":"Marwood","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunil","family":"Mistry","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Veronica","family":"O\u2019Keane","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9421-9158","authenticated-orcid":false,"given":"Stephanie Knatz","family":"Peck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hollie","family":"Simmons","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Sisa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan C.","family":"Stansfield","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joyce","family":"Tsai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sam","family":"Williams","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ekaterina","family":"Malievskaia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,7,13]]},"reference":[{"key":"1648_CR1","doi-asserted-by":"publisher","first-page":"12097","DOI":"10.1200\/JCO.2022.40.16_suppl.12097","volume":"40","author":"M Agrawal","year":"2022","unstructured":"Agrawal M, Thambi PM, Shnayder S. 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An independent contract research organization (Worldwide Clinical Trials) were responsible for conducting MADRS assessments with blinded remote raters. The analysis of the data was performed by the contract research organization (Worldwide Clinical Trials); and the interpretation of the data was performed by the sponsor. GMG has consulted for Beckley Psytech, Boehringer Ingelheim, Clerkenwell Health, EVApharm, H Lundbeck A\/S, Janssen Global Services, Novartis, Ocean Neurosciences, P1vital, Sage Therapeutics, Servier, Takeda and WebMD. GMG, MC, LM, SM, HS, CS, SCS, JT, SW, and EM are current or past employees of COMPASS Pathfinder. GMG, MC, LM, SM, HS, CS, JT, SW, and EM own shares or options in COMPASS Pathfinder. DF has received grant funding from MindMed, Neurolief, Perception Neuroscience, and Relmada Therapeutics. DF holds a patent for psychedelic drug treatment of neuropsychiatric disorders and cerebral palsy. DF, JRK, VOK, and SK-P were site investigators or sub-investigators for COMPASS Pathfinder during the clinical trial and received funding to conduct the study, and SK-P is a consultant for COMPASS Pathfinder, providing therapist training and mentorship, and clinical development. JRK has consulted for Clerkenwell Health and has received grant funding from the Health Research Board (ILP-POR-2022-030).","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}