[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lars Vedel Kessing\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100629238","phase-2-melatonin-versus-placebo-for-bipolar-disorder-100629238",false,"NCT07472075","Melatonin Versus Placebo for Bipolar Disorder","Melatonin Versus Placebo for Bipolar Disorder - a Double Blinded Randomised Controlled Trial","M-bipolar RCT","Inclusion Criteria:\n\n* Bipolar disorder with diagnosis confirmed by SCAN interview\n* Age 18 - 70 years\n* The participants must be able to read and understand the participant information in their native language and consent (English and Danish)\n* Habile (i.e able to give informed consent)\n\nExclusion Criteria:\n\n* Past intolerance to melatonin (allergic reactions)\n* Impaired renal or hepatic function (defined by GFR \\\u003C60 ml\u002Fmin and\u002For ALAT over allowed reference value)\n* Women who are pregnant, breastfeeding or planning pregnancy in near future.","ALL","18 Years","70 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The objective with this study is to conduct a 6-month RCT comparing effects of add-on melatonin versus add-on placebo on mood stabilisation and other critical patient outcomes in patients with BD and to test whether principal effects are antimanic, antidepressant and\u002For prophylactic against relapse",[28],"Bipolar Affective Disorder",[30,31,32,33,34],"Melatonin","Bipolar disorder","Mental disorders","Bipolar and related disorders","Mood disorder","RECRUITING","2026-05-07",{"date":38,"type":39},"2026-05-12","ACTUAL",{"date":41,"type":39},"2026-05-08",{"date":43,"type":22},"2028-06",{"name":45,"class":46},"Lars Vedel Kessing","OTHER",""]