[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629238":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":56,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University Hospital Bispebjerg and Frederiksberg","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Melatonin","ACTIVE_COMPARATOR","100 BD patients will receive 6 mg melatonin every evening. Patients, clinicians and researchers will be blinded.",[13],"Drug: Melatonin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","100 BD patients will receive placebo. Patients, clinicians and researchers will be blinded.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Oral: Melatonin capsule 6 mg, 1 capsule\u002Fday",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Oral Placebo capsule, 1 capsule\u002Fday",[15],[30],{"name":31,"affiliation":32,"role":33},"Lars Kessing","University hospital Bispebjerg and Frederiksberg Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+45 38647081","lars.vedel.kessing@regionh.dk",[40],{"facility":41,"status":42,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Mental Health Center Copenhagen, Copenhagen Affective Research Center (CADIC)","RECRUITING","Frederiksberg","2000","Denmark","DK",{"type":48,"coordinates":49},"Point",[50,51],12.53463,55.67938,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":37,"phoneExt":25,"email":38},"Lars Vedel Kessing",{"type":57,"investigatorFullName":55,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Professor","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":71,"type":72},200,"ESTIMATED","INTERVENTIONAL",[75],"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",[78],"Bipolar Affective Disorder",[9,80,81,82,83],"Bipolar disorder","Mental disorders","Bipolar and related disorders","Mood disorder","2026-05-07",{"date":86,"type":87},"2026-05-12","ACTUAL",{"date":89,"type":87},"2026-05-08",{"date":91,"type":72},"2028-06",{"name":55,"class":6},1]