Evaluation of Dalia Solution For Depressed Patient

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-76
SponsorDalia Care

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dalia Monitoring
  • Conventional healthcare

Treatment groups

644 Participants
are divided into 2 treatment groups

Sponsors and collaborators