[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609240":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":65,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":91,"overallStatus":99,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Dalia Care","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","ACTIVE_COMPARATOR","Patients assigned to the \"control\" group will follow conventional healthcare. According to french \"Haute Autorité de Santé\", conventional management includes advice on adopting a healthy lifestyle, psychotherapy with a contracted psychologist, and the prescription of antidepressants if necessary. In this case, regular medical follow-up by the general practitioner or psychiatrist is recommended, particularly at the start of antidepressant treatment (notably after the first and second week). Follow-up consultations to assess treatment response should be performed by the physician between M1 and M2, then at M3, M6, and M12, with a frequency adapted according to the clinical evolution of the patient",[13],"Other: Conventional healthcare",{"label":15,"type":16,"description":17,"interventionNames":18},"Interventional Arm","EXPERIMENTAL","Patients assigned to the \"intervention\" group will benefit from Dalia telemonitoring in addition to conventional management.",[19],"Device: Dalia Monitoring",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Dalia Monitoring","All patients consulting psychiatrists and general practitioners in participating centers, meeting all eligibility criteria and agreeing to participate in the study, will be consecutively selected and randomized into one of the two groups. For iInterventional arm: Patients will benefit from Dalia telemonitoring, in addition to conventional care.",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"OTHER","Conventional healthcare","All patients consulting psychiatrists and general practitioners in participating centers, meeting all eligibility criteria and agreeing to participate in the study, will be consecutively selected and randomized into one of the two groups. For Control arm: Patients in this group will benefit from the conventional care pathway.",[9],[33],{"name":34,"affiliation":5,"role":35},"Stéphane Mouchabac, Doctor","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Nour Hakiki Belhadi","CONTACT","+33758082693","nour@daliacare.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Alexis Bourla","+33 1 87 66 87 44","contact@neurostimfrance.com",[47],{"facility":48,"status":26,"city":49,"state":26,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Neurostim Luxembourg","Paris","75005","France","FR",{"type":54,"coordinates":55},"Point",[56,57],2.3488,48.85341,{"lat":57,"lon":56},[60,63],{"name":43,"role":39,"phone":26,"phoneExt":61,"email":62},"+33187668744","paris5@neurostimfrance.com",{"name":64,"role":35,"phone":26,"phoneExt":26,"email":26},"Stéphane Mouchabac, Pr",{"type":66,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":79,"type":80},644,"ESTIMATED","INTERVENTIONAL",[83],"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",[86,87,88,89,90],"Depression Chronic","Depressed","Depressed Mood","Depression and Quality of Life","Depression Diagnosis",[92,93,94,95,96,97,98],"Depression","PHQ-9","MADRS","Depressive episode","Anxiety disorder","Antidepressant prescriptions","Smartwatch","NOT_YET_RECRUITING","2025-10-01",{"date":102,"type":103},"2025-10-08","ACTUAL",{"date":105,"type":80},"2025-10-10",{"date":107,"type":80},"2026-03-31",{"name":5,"class":6},1]