{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T02:37:24Z","timestamp":1767926244027,"version":"3.49.0"},"reference-count":42,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,7,3]],"date-time":"2020-07-03T00:00:00Z","timestamp":1593734400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health Research","doi-asserted-by":"publisher","award":["RC\u2010PG\u20100407\u201010155"],"award-info":[{"award-number":["RC\u2010PG\u20100407\u201010155"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Bipolar Disorders"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>Current options for treating emergent episodes of hypomania and mania in bipolar disorder are limited. Our objective was to compare the effectiveness and safety of add\u2010on melatonin in hypomania or mania over 3\u00a0weeks as a well\u2010tolerated therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A randomized, double\u2010blind, parallel\u2010group, 3\u2010week comparison of modified release melatonin (n\u00a0=\u00a021) vs placebo (n\u00a0=\u00a020) in adult bipolar patients aged 18\u201065\u00a0years. Permuted block randomization was used with participants and investigators masked to treatment allocation. Trial registration is ISRCTN28988273 and EUdraCT2008\u2010000281\u201023. Approved by the South Central National Research Ethics Service (Oxford REC A) ref: 09\/H0604\/63.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The trial was negative as there was no significant difference between melatonin and placebo on the primary outcome\u2014mean Young Mania Rating Scale (YMRS) score at Day 21: (mean difference [MD] \u22121.77 ([95% CI: \u22126.39 to 2.85]; <jats:italic>P<\/jats:italic>\u00a0=\u00a0.447). Significantly fewer patients on melatonin scored 10 or more on the Altman Self Rating Mania Scale: (odds ratio [OR] 0.164 [95% CI: 0.0260\u20101.0002]; <jats:italic>P<\/jats:italic>\u00a0=\u00a0.05). Quick Inventory of Depression Symptomatology Clinician Version\u201016 (QIDS\u2010C16) scores were not significantly different. (OR 1.77 [95% CI: 0.43\u20107.29]; <jats:italic>P<\/jats:italic>\u00a0=\u00a0.430). The proportion of patients scoring less than or equal to 5 on the self\u2010report QIDS\u2010SR16 at end\u2010point was greater for the melatonin group (OR 8.35 [95% CI: 1.04\u201067.23]; <jats:italic>P<\/jats:italic>\u00a0=\u00a0.046).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In this small trial, melatonin did not effectively treat emerging hypomania or mania as there was no significant difference on the primary outcome. The sample size limitation and secondary outcomes suggest further investigation of melatonin treatment in mood episodes is indicated.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bdi.12944","type":"journal-article","created":{"date-parts":[[2020,5,31]],"date-time":"2020-05-31T19:05:00Z","timestamp":1590951900000},"page":"176-185","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Melatonin In Acute Mania Investigation (MIAMI\u2010UK). A randomized controlled trial of add\u2010on melatonin in bipolar disorder"],"prefix":"10.1111","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6155-3336","authenticated-orcid":false,"given":"Digby J.","family":"Quested","sequence":"first","affiliation":[{"name":"Oxford Health NHS Foundation Trust Warneford Hospital Oxford UK"},{"name":"Department of Psychiatry University of Oxford Warneford Hospital Oxford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessica C.","family":"Gibson","sequence":"additional","affiliation":[{"name":"Oxford Health NHS Foundation Trust Warneford Hospital Oxford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ann L.","family":"Sharpley","sequence":"additional","affiliation":[{"name":"Department of Psychiatry University of Oxford Warneford Hospital Oxford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julia H.","family":"Cordey","sequence":"additional","affiliation":[{"name":"Oxford Health NHS Foundation Trust Warneford Hospital Oxford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexis","family":"Economou","sequence":"additional","affiliation":[{"name":"Oxford Health NHS Foundation Trust Warneford Hospital Oxford UK"},{"name":"Berkshire NHS Foundation Trust Prospect Park Hospital Reading Berkshire UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Franco","family":"De Crescenzo","sequence":"additional","affiliation":[{"name":"Oxford Health NHS Foundation Trust Warneford Hospital Oxford UK"},{"name":"Department of Psychiatry University of Oxford Warneford Hospital Oxford UK"},{"name":"Pediatric University Hospital\u2010Department (DPUO) Bambino Ges\u00f9 Children's Hospital Rome Italy"},{"name":"Department of Epidemiology Lazio Regional Health Service Rome Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Merryn","family":"Voysey","sequence":"additional","affiliation":[{"name":"Nuffield Department of Primary Care Health Sciences University of Oxford Oxford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer","family":"Lawson","sequence":"additional","affiliation":[{"name":"Oxford Health NHS Foundation Trust Warneford Hospital Oxford UK"},{"name":"Department of Psychiatry University of Oxford Warneford Hospital Oxford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer M.","family":"Rendell","sequence":"additional","affiliation":[{"name":"Department of Psychiatry University of Oxford Warneford Hospital Oxford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hasanen","family":"Al\u2010Taiar","sequence":"additional","affiliation":[{"name":"Oxford Health NHS Foundation Trust Warneford Hospital Oxford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alison","family":"Lennox","sequence":"additional","affiliation":[{"name":"Oxford Health NHS Foundation Trust Warneford Hospital Oxford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Farooq","family":"Ahmad","sequence":"additional","affiliation":[{"name":"Berkshire NHS Foundation Trust Prospect Park Hospital Reading Berkshire UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John R.","family":"Geddes","sequence":"additional","affiliation":[{"name":"Oxford Health NHS Foundation Trust Warneford Hospital Oxford UK"},{"name":"Department of Psychiatry University of Oxford Warneford Hospital Oxford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,7,3]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)61611-6"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)60873-8"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)60857-0"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2013.13020185"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40345-014-0015-8"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)61516-X"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v58n0902"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0278-5846(99)00097-4"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/acps.12755"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1497.2005.0243.x"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.smrv.2004.06.004"},{"key":"e_1_2_8_13_1","first-page":"1","article-title":"Melatonin for treatment of sleep disorders","volume":"108","author":"Buscemi N","year":"2004","journal-title":"Evid Rep Technol Assess (Summ)"},{"issue":"2","key":"e_1_2_8_14_1","first-page":"CD001520","article-title":"Melatonin for the prevention and treatment of jet lag","author":"Herxheimer A","year":"2002","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.bp.108.050955"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2010-1031"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2014.07.002"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/bdi.12270"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2012.667076"},{"key":"e_1_2_8_20_1","volume-title":"Diagnostic and Statistical Manual of Mental Disorders","author":"American Psychiatric Association","year":"1994"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.133.5.429"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-015-1873-4"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0006-3223(96)00548-3"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0006-3223(02)01866-8"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.smrv.2016.05.003"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/hup.455"},{"issue":"1","key":"e_1_2_8_27_1","first-page":"CD004043","article-title":"Risperidone alone or in combination for acute mania","author":"Rendell JM","year":"2006","journal-title":"Cochrane Database Syst Rev"},{"issue":"3","key":"e_1_2_8_28_1","first-page":"CD004040","article-title":"Olanzapine alone or in combination for acute mania","author":"Rendell JM","year":"2003","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1001\/archpsyc.59.1.62"},{"key":"e_1_2_8_30_1","first-page":"84","article-title":"How to measure circadian rhythms in humans","volume":"29","author":"Wirz\u2010Justice A","journal-title":"Medicographia"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1097\/YIC.0000000000000046"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1080\/07420520500545862"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1113\/jphysiol.2007.143180"},{"key":"e_1_2_8_34_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2009-2590"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsmc.2009.02.003"},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.0602425103"},{"key":"e_1_2_8_37_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.psychres.2009.04.009"},{"key":"e_1_2_8_38_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41398-018-0255-y"},{"key":"e_1_2_8_39_1","doi-asserted-by":"publisher","DOI":"10.1111\/nyas.13048"},{"key":"e_1_2_8_40_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2215-0366(18)30139-1"},{"key":"e_1_2_8_41_1","doi-asserted-by":"publisher","DOI":"10.1111\/bdi.12390"},{"key":"e_1_2_8_42_1","unstructured":"Wirz\u2010JusticeA BenedettiF TermanM.Chronotherapeutics for Affective Disorders\u2014A Clinician's Manual for Light and Wake Therapy 2nd revised edn.Karger.2013. ISBN: 978\u20103\u2010318\u201002090\u20108; e\u2010ISBN: 978\u20103\u2010318\u201002091\u20105."},{"key":"e_1_2_8_43_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygcen.2017.07.010"}],"container-title":["Bipolar Disorders"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bdi.12944","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/bdi.12944","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bdi.12944","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,1]],"date-time":"2023-09-01T11:37:06Z","timestamp":1693568226000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/bdi.12944"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,7,3]]},"references-count":42,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2021,3]]}},"alternative-id":["10.1111\/bdi.12944"],"URL":"https:\/\/doi.org\/10.1111\/bdi.12944","archive":["Portico"],"relation":{},"ISSN":["1398-5647","1399-5618"],"issn-type":[{"value":"1398-5647","type":"print"},{"value":"1399-5618","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,7,3]]},"assertion":[{"value":"2020-07-03","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}