[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494107":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":42,"responsibleParty":72,"collaborators":74,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":26,"enrollmentInfo":87,"targetDuration":26,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Ciusss de L'Est de l'Île de Montréal","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Enteral melatonin 9 mg","EXPERIMENTAL","Melatonin 9 mg from a 1 mg\u002FmL oral suspension of melatonin in ORA-BLEND SF® (sugar-free flavoured suspending vehicle). Final volume in the oral syringe will be 9 mL.",[13],"Drug: Melatonin",{"label":15,"type":16,"description":17,"interventionNames":18},"Enteral placebo","PLACEBO_COMPARATOR","ORA-BLEND SF® (sugar-free flavoured suspending vehicle). Final volume in the oral syringe will be 9 mL.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Melatonin","Study drug will be given at 21:00 daily, starting on the day of enrolment until delirium resolution, hospital discharge, death, or up to 14 days. The study medication will be given by mouth (PO or per os) or, if needed, via the feeding tube.",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Placebo",[15],[31],{"name":32,"affiliation":33,"role":34},"François Marquis, M.D., M.A.","Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est-de-l'Île-de-Montréal","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Johannie Beaucage-Charron, Pharm.D., M.Sc.","CONTACT","514 252 3400","6125","johannie.beaucage-charron.cemtl@ssss.gouv.qc.ca",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Hopital Maisonneuve-Rosemont","RECRUITING","Montreal","Quebec","H1T 2M4","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-73.58781,45.50884,{"lat":55,"lon":54},[58,59,62,64,66,68,70],{"name":37,"role":38,"phone":26,"phoneExt":26,"email":26},{"name":60,"role":61,"phone":26,"phoneExt":26,"email":26},"Katerine Chalifoux, Pharm.D.","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":26,"phoneExt":26,"email":26},"Marianne Leblanc, Pharm.D.",{"name":65,"role":61,"phone":26,"phoneExt":26,"email":26},"Mounia Louerguioui, Pharm.D.",{"name":67,"role":61,"phone":26,"phoneExt":26,"email":26},"Patricia Poirier, Pharm.D.",{"name":69,"role":61,"phone":26,"phoneExt":26,"email":26},"Aryane Roy, B.Pharm.",{"name":71,"role":61,"phone":26,"phoneExt":26,"email":26},"Winnie Tran, Pharm.D.",{"type":73,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[75],{"name":76,"class":6},"Maisonneuve-Rosemont Hospital","100494107","phase-2-melatonin-for-treatment-of-delirium-in-critically-ill-adult-patients-100494107",false,"NCT05713877","Melatonin for Treatment of Delirium in Critically Ill Adult Patients","DELIRE-ICU: A Randomised Controlled Feasibility Trial of Melatonin vs Placebo in the Treatment of Delirium in the Intensive Care Unit","DELIRE-ICU","Inclusion Criteria:\n\n* Patients aged 18 years or older admitted to the intensive care unit;\n* Anticipated ICU stay \\> 48 hours;\n* ICDSC score greater than or equal to 4 for a maximum of 48 hours prior to randomization.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to melatonin or to ingredients in ORA-BLEND SF®;\n* Use of melatonin within 24 hours prior to randomization;\n* Presence of severe structural brain injury (intracranial hemorrhage or traumatic brain injury), severe major neurocognitive disorder, advanced neurodegenerative disease or hepatic encephalopathy;\n* Diagnosis of schizophrenia, bipolar affective disorder, psychotic depression, uremic encephalopathy or alcohol withdrawal;\n* Presence of active seizures, coma, aphasia or severe intellectual disability;\n* Limited short-term vital prognosis;\n* Diagnosis of delirium prior to ICU admission;\n* Pregnancy or breastfeeding;\n* Absolute contraindication to receive enteral medication;\n* Inability to understand or speak English or French;\n* Total blindness.","ALL","18 Years",{"count":88,"type":89},30,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","The purpose of this study is to determine the feasibility of conducting a randomized controlled trial (RCT) with melatonin for treatment of delirium in critically ill adult patients. From a feasibility perspective, the investigators believe that the proposed design will achieve the minimum enrollment rate necessary to conduct a future RCT on a larger scale.",[95],"Delirium",[23,97,98,99,100,101],"Intensive care","Feasibility","Treatment","Critically ill","ICU","2026-03-19",{"date":104,"type":105},"2026-03-23","ACTUAL",{"date":107,"type":105},"2023-02-01",{"date":109,"type":89},"2026-12-30",{"name":5,"class":6},1]