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/OR a PHQ-9 score lower than 15. The threshold of 5 points is the Minimal Clinically Important Difference (MCID) of the PHQ-9 scale
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 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
Parallel
Dalia Monitoring
DeviceAll 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.
Conventional healthcare
Other interventionAll 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.
Primary Endpoint
The primary endpoint will be 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/OR a PHQ-9 score lower than 15. The threshold of 5 points is the Minimal Clinically Important Difference (MCID) of the PHQ-9 scale
This trial is not recruiting at the moment. You can still explore other options:
