Detection Algorithm for Recurrence or Relapse of Depression Thanks to a Smartwach

Globally, 3.8% of the population, or approximately 280 million people, suffer from depression. In France, 12.5% of adults experienced a major depressive episode (MDE) in 2021, with women being twice as affected as men. MDEs often require pharmacological treatment, but only one-third of patients achieve full remission after eight weeks of treatment. Relapse and recurrence are common, especially after the first episode, with the risk increasing with each subsequent episode. Depression significantly impacts morbidity, mortality, and functioning, and is the leading predictor of suicide. The Dalia mobile application, developed collaboratively with patients and psychiatrists, uses a smartwatch to monitor physiological parameters (e.g., heart activity, sleep quality, moods) to detect early signs of relapse or recurrence. This study aims to identify variations in clinical biomarkers during remission or recovery and validate Dalia's sensitivity in detecting relapse compared to psychiatric diagnosis. Early detection could improve depression management and reduce the burden of the disease.

NCT Number	NCT06789822
Lead Sponsor	Dalia Care Collaborators: Digital Medical Hub
Conditions	Depressive Disorder, Depressive Disorder, Major Depressive Disorder, Depressive Disorder Not Otherwise Specified (NOS)
Enrollment	800 participants
Start Date	2024-12-19
Primary Completion	2025-08-18 (estimated)
Study Completion	2026-02-18 (estimated)
Updated on ClinicalTrials.gov	2025-01-23