[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520929":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":34,"centralContacts":39,"locations":44,"responsibleParty":55,"collaborators":59,"id":68,"slug":11,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":82,"briefSummary":85,"conditions":86,"keywords":11,"overallStatus":46,"whyStopped":11,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Copenhagen","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Melatonin","EXPERIMENTAL",null,[13],"Drug: Melatonin",{"label":15,"type":10,"description":11,"interventionNames":16},"Quetiapine",[17],"Drug: Quetiapine",{"label":19,"type":20,"description":11,"interventionNames":21},"Placebo","PLACEBO_COMPARATOR",[22],"Drug: Placebo",[24,28,31],{"type":25,"name":9,"description":26,"armGroupLabels":27,"otherNames":11},"DRUG","3-9 mg flexible dosing before bed time",[9],{"type":25,"name":15,"description":29,"armGroupLabels":30,"otherNames":11},"50-150 mg flexible dosing before bed time",[15],{"type":25,"name":19,"description":32,"armGroupLabels":33,"otherNames":11},"1-3 capsules flexible dosing before bed time",[19],[35],{"name":36,"affiliation":37,"role":38},"Lone Baandrup, MD","Mental Health Center Copenhagen","PRINCIPAL_INVESTIGATOR",[40],{"name":36,"role":41,"phone":42,"phoneExt":11,"email":43},"CONTACT","+4591165903","lone.baandrup@regionh.dk",[45],{"facility":37,"status":46,"city":47,"state":11,"zip":48,"country":49,"cosmosGeoPoint":11,"geoPoint":11,"contacts":50},"RECRUITING","Copenhagen NV","2400","Denmark",[51],{"name":52,"role":41,"phone":53,"phoneExt":11,"email":54},"Ursula Brinck-Claussen, MD","+4520483136","ursula.oedum.brinck-claussen@regionh.dk",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Lone Baandrup","Sponsor-investigator",[60,62,64,66],{"name":61,"class":6},"Danish Center for Sleep Medicine",{"name":63,"class":6},"Region Capital Denmark",{"name":65,"class":6},"Copenhagen Trial Unit, Center for Clinical Intervention Research",{"name":67,"class":6},"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital","100520929",false,"NCT06062953","Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia","Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia: a Randomized Clinical Trial","MEL-QUE","Inclusion Criteria:\n\n* 16 to 64 years of age\n* ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-95)\n* For the diagnoses F84 and F90 a previous period of treatment with melatonin is required\n* For the 16-17 years old: Non-pharmacological treatment options including sleep hygiene education, weighted blanket or other gravity products have been tested with insufficient effect\n* Self-reported sleep difficulties at least three times per week in the preceding 3 months\n* Insomnia Severity Index score ≥11\n* Women of childbearing potential: negative pregnancy test at baseline and use of highly effective contraception measures\n* Informed consent\n\nExclusion Criteria:\n\n* Current treatment with melatonin or quetiapine\n* Severe somatic comorbidity\n* BMI ≥ 35 kg\u002Fm2\n* Breastfeeding\n* Alcohol and\u002For substance dependency within the last 3 months\n* Inadequate Danish language skills\n* Not able to make an informed consent\n* Increased cardiac risk as assessed by presence of cardiac risk factors, cardiac symptoms, or prolonged QT-interval at baseline ECG","ALL","16 Years","64 Years",{"count":79,"type":80},255,"ESTIMATED","INTERVENTIONAL",[83,84],"PHASE2","PHASE3","The goal of this investigator-initiated, randomized, blinded, 3-armed placebo-controlled, pragmatic, clinical superiority trial is to examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia in patients with psychiatric disorders. The aims of the study are:\n\n* To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia\n* To examine how melatonin or low-dose quetiapine affects global symptom severity, sleep quality, psychosocial functioning and subjective well-being.\n\nParticipants will receive six weeks of treatment with either melatonin, quetiapine or placebo followed by a brief taper off.",[87,88],"Psychiatric Disorders","Insomnia","2025-04-21",{"date":91,"type":92},"2025-04-24","ACTUAL",{"date":94,"type":92},"2023-09-18",{"date":96,"type":80},"2029-02-28",{"name":57,"class":6},1]