[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rayan NASSERDINE\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"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":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100573625","effect-of-blue-light-blocking-on-reducing-manic-symptoms-in-bipolar-disorder-100573625",false,"NCT06748716","Effect of Blue Light Blocking on Reducing Manic Symptoms in Bipolar Disorder","Effect of Blue Light Blocking on Reducing Manic Symptoms in Bipolar Disorder: a Randomized Placebo-controlled Trial BLUME (Blue Light Filtering in Manic Episodes)","BLUME","Inclusion Criteria:\n\n* Patients hospitalized with manic symptoms in HUG\n* Diagnostic of Bipolar Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria\n* aged 18-70 years\n\nExclusion Criteria:\n\n* previous knowledge of blue-blocking glasses\n* not consenting to participate\n* severe eye disease or traumatic injury affecting both eyes.\n* withdrawal symptoms from any drug or alcohol at the time of admission (the start of the intervention will be delayed until withdrawal symptoms have ceased)","ALL","18 Years","70 Years",{"count":21,"type":22},96,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study will be a randomized controlled trial (RCT) measuring the efficacy of wearing blue-blocking glasses (orange glasses) on manic symptoms in a population of patients suffering from Bipolar Disorder (BD), hospitalized for a manic episode on 10 days compared to non-filtering glasses (clear glasses, placebo) in addition to pharmacological treatment as usual.\n\nThe primary objective of this study is to evaluate the efficacity of orange glasses on improving manic symptoms in adult patients presenting BD in comparison with placebo. The primary outcome will be the change of total score of the Young Mania Rating Scale (YMRS) from baseline to day 10. Secondary objectives will be change in sleep quality, in motor activity (patterns of activity and rest), impact on psychotics symptoms, kinetics of the decrease of the manic symptoms from inclusion to the study and impact on maximal administered antipsychotic medication dosage ; they will be explored.\n\nThe investigators hypothesize that orange glasses is more effective than placebo in improving manic symptoms as an adjuvant treatment.\n\nThis project will take place in Alizé unit which is a newly conceived specialized ward dedicated to treating BD, at the HUG. The methodology has been developed in collaboration with the center of clinical research (CRC). The study will be conducted in accordance with established ethical and data management\u002Fprotection practices.",[28,29,30,31,32,33,34,35],"Bipolar","Manic","Bipolar Disorder (BD)","Dark Therapy","Actigraphy","Mania","RCT","Virtual Darkness","NOT_YET_RECRUITING","2024-12-18",{"date":39,"type":40},"2024-12-27","ACTUAL",{"date":42,"type":22},"2025-04-01",{"date":44,"type":22},"2028-04-01",{"name":46,"class":47},"Rayan NASSERDINE","OTHER",""]