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ACTIVE NOT RECRUITING
NCT06789822
NA

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

Sponsor: Dalia Care

View on ClinicalTrials.gov

Summary

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.

Official title: Calibration of the Early Detection Algorithm for Recurrence or Relapse of a Major Depressive Episode Via Clinical Biomarkers Collected by a Smartwatch

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2024-12-19

Completion Date

2026-02-18

Last Updated

2025-01-23

Healthy Volunteers

No

Interventions

DEVICE

Invitation to wear the smartwatch

During a consultation with the psychiatrist, and after verifying the eligibility criteria, the patient will receive oral information about the study from the psychiatrist.

Locations (1)

Hôpital Saint-Antoine

Paris, France