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

NCT06789822 | Active Not Recruiting

• 1 other identifier: 2024-A01982-45
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Algorithm; Early Detection; Recurrence; Relapse; Major Depressive Episode; Clinical Biomarker; Smartwatch

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Relapse (during remission) or Recurrence (after Recovery)

  Detection of a relapse (during remission) or a recurrence (after recovery) in patients in remission or recovery from a major depressive episode (MDE), using physiological (clinical) data collected via a smartwatch.

  From enrollment to the end of calibration at 8 months

Study Arms (1)

Patients included

EXPERIMENTAL

The Arm of patients invited to wear smartwatch during the study

Device: Invitation to wear the smartwatch

Interventions

Invitation to wear the smartwatch DEVICE

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

Patients included

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Patient in remission or recovery from a major depressive episode (MDE), confirmed by a psychiatrist with a Montgomery and Åsberg Depression Rating Scale (MADRS) score ≤ 7, within a maximum of 6 months after the last MDE;
• Patient speaks French;
• Patient owns a smartphone, computer, or tablet with internet/cellular data access;
• Patient resides in France and is affiliated with a social security scheme.

You may not qualify if:

• Patient taking non-cardioselective beta-blockers (carvedilol, labetalol, propranolol, pindolol) and beta-mimetics (salbutamol, terbutaline);
• Patient with a pacemaker or known cardiac rhythm disorder;
• Patient with substance use disorders in the past six months (alcohol or drug abuse);
• Patient with dementia, mental disorders, cognitive impairments, or psychiatric conditions that could compromise their participation in the study and/or adherence to the study protocol: suicide risk, dementia, schizophrenia or other psychotic disorders, bipolar disorder, anxiety disorders including panic disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder, psychotic depression, or depression secondary to brain disorders;
• Patient under guardianship, curatorship, or any other administrative or judicial measure restricting rights and freedom;
• Patient deemed non-autonomous by the investigator;
• Patient unable to wear the smartwatch for the duration of the study.

Sponsors & Collaborators

• Dalia Care: lead
• Digital Medical Hub: collaborator

Study Sites (1)

Hôpital Saint-Antoine

Paris, 75012, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder; Depressive Disorder, Major; Recurrence

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an observational, prospective, multicenter study (data collection). The data collected will be derived from information obtained as part of routine care.

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: December 19, 2024
• Primary Completion: August 18, 2025
• Study Completion: February 18, 2026
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)