Status:
NOT_YET_RECRUITING
Evaluation of Dalia Solution For Depressed Patient
Lead Sponsor:
Dalia Care
Conditions:
Depression Chronic
Depressed
Eligibility:
All Genders
18-76 years
Phase:
NA
Brief Summary
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 m...
Detailed Description
Worldwide, depression is a disease that affects 3.8% of the population, i.e., about 280 million people \[1\]. INSERM specifies that major depressive disorder affects all ages of life and concerns abou...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- 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
- Patient receiving a first antidepressant treatment (treatment-naïve) OR having had a modification of antidepressant treatment in the two weeks prior to inclusion
- Patient equipped with a smartphone or a computer or a tablet with internet access
- Patient affiliated to a health insurance scheme
- Patient able to read and understand French
- Patient having signed informed consent
Exclusion
- Patient under non-cardioselective beta-blocker (carvedilol, labetalol, propranolol, pindolol) and beta-mimetic (salbutamol, terbutaline)
- Patient with a pacemaker or with a known cardiac arrhythmia
- Patient with major neurocognitive disorder (e.g., dementia) or psychotic disorders likely to compromise participation in the study
- Patient hospitalized at the time of inclusion whose discharge is not planned within the next two weeks
- Patient treated with esketamine
- Patient with excessive consumption of psychoactive substances (alcohol or drugs), which may interfere with the course or follow-up of the study
- Patient unable to wear the bracelet during the study due to dermatological conditions
- Patient under guardianship, curatorship, or legal protection, or any other administrative or judicial measure depriving rights and freedom
- Patient considered non-autonomous by the investigator
- Patient already included in another interventional research study
- 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
Key Trial Info
Start Date :
October 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
644 Patients enrolled
Trial Details
Trial ID
NCT07211984
Start Date
October 10 2025
End Date
March 31 2026
Last Update
October 8 2025
Active Locations (1)
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1
Neurostim Luxembourg
Paris, France, 75005