[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lone Baandrup\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100520929","phase-2-efficacy-of-melatonin-low-dose-quetiapine-or-placebo-in-patients-with-psychiatric-disorders-and-comorbid-insomnia-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":21,"type":22},255,"ESTIMATED","INTERVENTIONAL",[25,26],"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.",[29,30],"Psychiatric Disorders","Insomnia","RECRUITING","2025-04-21",{"date":34,"type":35},"2025-04-24","ACTUAL",{"date":37,"type":35},"2023-09-18",{"date":39,"type":22},"2029-02-28",{"name":41,"class":42},"Lone Baandrup","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":19,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100573925","phase-2-acute-agitation-in-emergency-psychiatry-100573925","NCT06752616","Acute Agitation in Emergency Psychiatry","Advancing the Quality of Treatment and Care for Acute Agitation in Emergency Psychiatry","Inclusion Criteria:\n\n* 18-64 years\n* Agitation with the need for tranquillization in inpatient psychiatric settings including psychiatric emergency rooms\n* Total score of ≥14 on the PANSS Excited Component (PEC)\n* A score ≥4 on at least 1 of the 5 items of the PEC\n* Informed consent obtained prior to the occurrence of the emergency\n\nExclusion Criteria:\n\n* Involuntary psychiatric admission according to the Danish Mental Health Act\n* Female patients who are breastfeeding\n* Female patients aged \\\u003C50 years and unable to perform a negative urine screen for pregnancy and not using safe contraceptives\n* Body weight \\\u003C50 kg\n* Extreme obesity defined as estimated BMI≥ 40 kg\u002Fm2\n* Clinical situations where acute administration of an antipsychotic is preferred to treat acute agitation (in the opinion of the investigator)\n* The patient deemed unwilling or unable to cooperate with study procedures (in the opinion of the investigator)\n* Insufficient language skills that interfere with reading, writing, and providing written informed consent in Danish or other available languages (in the opinion of the investigator)\n* Clinical suspicion of contraindications for one of the treatment arms\n* Use of benzodiazepines, other sedatives, or antipsychotic drugs in addition to usual treatment (i.e., additional PN sedative prescriptions) in the 4 hours before study treatment\n* Known allergy to any of the study medications","18 Years",{"count":53,"type":22},132,[25,26],"The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.",[57],"Agitation",[59],"Emergency psychiatry","2024-12-30",{"date":62,"type":35},"2025-01-01",{"date":60,"type":35},{"date":65,"type":22},"2027-12",{"name":41,"class":42},""]