NCT06789822Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 23 Jan 2025

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Study type: Interventional
Enrollment: 800 (estimated)
First submitted: 17 Jan 2025
Start date: 19 Dec 2024
Primary completion date: 18 Aug 2025
Lead sponsor: Dalia Care
Diseases: Depression
NCT number: NCT06789822

What you commit to

Study type: Interventional
Planned participants: 800
From 19 Dec 2024 to the primary completion date, 18 Aug 2025
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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;

Other

Patient taking non-cardioselective beta-blockers (carvedilol, labetalol, propranolol, pindolol) and beta-mimetics (salbutamol, terbutaline);
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.

Who the study is looking for

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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Hôpital Saint-Antoine Coordinator of this site? Confirm its status	Paris	France	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.