Depressive DisorderDepressive Disorder, Major Depressive DisorderDepressive Disorder Not Otherwise Specified (NOS)
Investigational drug(s) / intervention(s)
Invitation to wear the smartwatch
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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Number of Patients with Relapse (during remission) or Recurrence (after Recovery) — From enrollment to the end of calibration at 8 months 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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