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

NCT06789822 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2025-01-23

No results posted yet for this study

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.

Conditions

  • Depressive Disorder
  • Depressive Disorder, Major Depressive Disorder
  • Depressive Disorder Not Otherwise Specified (NOS)

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.

Sponsors & Collaborators

  • Digital Medical Hub

    collaborator OTHER

  • Dalia Care

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2025-08-18
Completion
2026-02-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06789822 on ClinicalTrials.gov