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In this trial (short name: PsiDeR) we aimed to test the feasibility of a parallel-group, randomised, placebo-controlled design. The primary outcomes in this trial are measures of feasibility: recruitment rates, dropout rates and the variance of the primary outcome measure of depression.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>We are recruiting up to 60 participants at a single centre in London, UK who are unresponsive to, or intolerant of, at least two evidence-based treatments for MDD. Participants are randomised to receive a single dosing session of 25\u2009mg psilocybin or a placebo. All participants receive a package of psychological therapy. The primary outcome measure for depression is the Montgomery Asberg Depression Rating Scale collected by blinded, independent raters. The primary endpoint is at 3 weeks, and the total follow-up is 6 weeks. With further informed consent, this study collects neuroimaging and omics data for mechanism and biomarker analyses and offers participants an open label extension consisting of a further, open label dose of 25\u2009mg of psilocybin.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>All participants will be required to provide written informed consent. The trial has been authorised by the National Research Ethics Committee (20-LO\/0206), Health Research Authority (252750) and Medicine\u2019s and Healthcare Products Regulatory Agency (CTA 14523\/0284\/001-0001) in the UK. Dissemination of results will occur via a peer-reviewed publication and other relevant media.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration numbers<\/jats:title>\n                    <jats:p>\n                      EUDRACT2018-003573-97;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04959253\">NCT04959253<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-056091","type":"journal-article","created":{"date-parts":[[2021,12,1]],"date-time":"2021-12-01T12:33:43Z","timestamp":1638362023000},"page":"e056091","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":25,"title":["Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct04959253","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4647-8088","authenticated-orcid":false,"given":"James","family":"Rucker","sequence":"first","affiliation":[{"name":"Department of Psychological Medicine, King\"s College London, London, UK"},{"name":"National Affective Disorders Service, South London and Maudsley NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hassan","family":"Jafari","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, King\"s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tim","family":"Mantingh","sequence":"additional","affiliation":[{"name":"Department of Psychological Medicine, King\"s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Bird","sequence":"additional","affiliation":[{"name":"Department of Psychological Medicine, King\"s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nadav Liam","family":"Modlin","sequence":"additional","affiliation":[{"name":"Department of Psychological Medicine, King\"s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gemma","family":"Knight","sequence":"additional","affiliation":[{"name":"Department of Psychological Medicine, King\"s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frederick","family":"Reinholdt","sequence":"additional","affiliation":[{"name":"Department of Psychological Medicine, King\"s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Camilla","family":"Day","sequence":"additional","affiliation":[{"name":"Department of Psychological Medicine, King\"s College London, London, UK"},{"name":"National Affective Disorders Service, South London and Maudsley NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0318-8865","authenticated-orcid":false,"given":"Ben","family":"Carter","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, King\"s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allan","family":"Young","sequence":"additional","affiliation":[{"name":"Department of Psychological Medicine, King\"s College London, London, UK"},{"name":"National Affective Disorders Service, South London and Maudsley NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,12,1]]},"reference":[{"key":"2025121512460870000_11.12.e056091.1","unstructured":"McCrone P , Dhanasiri S , Patel A . 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