[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depression-diagnosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depression-diagnosis":32},{"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":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"100609240","evaluation-of-dalia-solution-for-depressed-patient-100609240",false,"NCT07211984","Evaluation of Dalia Solution For Depressed Patient","Evaluation of the Clinical and Organizational Impact of the Digital Medical Device Dalia in the Management of Depression","DaliaMonitorin","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient with a diagnosis of depressive episode, as defined by ICD-11, and with a PHQ-9 score ≥ 15 confirmed by a psychiatrist or general practitioner\n* Patient receiving a first antidepressant treatment (treatment-naïve) OR having had a modification of antidepressant treatment in the two weeks prior to inclusion\n* Patient equipped with a smartphone or a computer or a tablet with internet access\n* Patient affiliated to a health insurance scheme\n* Patient able to read and understand French\n* Patient having signed informed consent\n\nExclusion Criteria:\n\n* Patient under non-cardioselective beta-blocker (carvedilol, labetalol, propranolol, pindolol) and beta-mimetic (salbutamol, terbutaline)\n* Patient with a pacemaker or with a known cardiac arrhythmia\n* Patient with major neurocognitive disorder (e.g., dementia) or psychotic disorders likely to compromise participation in the study\n* Patient hospitalized at the time of inclusion whose discharge is not planned within the next two weeks\n* Patient treated with esketamine\n* Patient with excessive consumption of psychoactive substances (alcohol or drugs), which may interfere with the course or follow-up of the study\n* Patient unable to wear the bracelet during the study due to dermatological conditions\n* Patient under guardianship, curatorship, or legal protection, or any other administrative or judicial measure depriving rights and freedom\n* Patient considered non-autonomous by the investigator\n* Patient already included in another interventional research study\n* Vulnerable persons referred to in Articles L.1121-5 to 8 and L.1122-1-2 of the French Public Health Code are excluded from the study","ALL","18 Years","76 Years",{"count":21,"type":22},644,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this superiority clinical investigation, prospective, multicenter, controlled, randomized, open-label is to evaluate the clinical impact of the Dalia medical telemonitoring device on the management of depressive patients. The main question it aims to answer is: the percentage of patients with clinically significant improvement at 3 months. A clinically significant improvement is defined as a decrease of at least 5 points from the initial PHQ-9 score AND\u002FOR a PHQ-9 score lower than 15. The threshold of 5 points is the Minimal Clinically Important Difference (MCID) of the PHQ-9 scale",[28,29,30,31,32],"Depression Chronic","Depressed","Depressed Mood","Depression and Quality of Life","Depression Diagnosis",[34,35,36,37,38,39,40],"Depression","PHQ-9","MADRS","Depressive episode","Anxiety disorder","Antidepressant prescriptions","Smartwatch","NOT_YET_RECRUITING","2025-10-01",{"date":44,"type":45},"2025-10-08","ACTUAL",{"date":47,"type":22},"2025-10-10",{"date":49,"type":22},"2026-03-31",{"name":51,"class":52},"Dalia Care","INDUSTRY"]