Using a wearable monitor to track physiological data in patients with major depression

Prospective, Multicenter Non-randomised, Open-label Study Evaluating the Correlation Between Physiological Data Measured by a Portable Sensor and Psychometric Assessment

This study tests if a wearable monitor that tracks things like heart rate and movement can help doctors understand and treat major depression better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Digital For Mental Health (Industry-sponsored)
• Locations: 11 sites (Bersée and 10 other locations)
• Trial ID: NCT05547035 on ClinicalTrials.gov

What this trial studies

This study evaluates the relationship between physiological data collected from a wearable monitor and clinical assessments in patients suffering from major depressive disorder over a six-month period. The wearable device measures electrodermal activity, motor activity, and heartbeat, which are then correlated with clinical evaluations performed by physicians. The goal is to better understand how these physiological indicators relate to the severity and treatment of depression.

Who should consider this trial

Good fit: Ideal candidates are adults experiencing a major depressive episode as defined by DSM V criteria, with a MADRS score of 20 or higher.

Not a fit: Patients with severe medical conditions, resistant depression, or those unable to wear the monitor may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for patients with major depressive disorder.

How similar studies have performed: While the use of wearable technology in mental health is an emerging field, similar studies have shown promise in correlating physiological data with mental health outcomes.

Eligibility criteria

Inclusion Criteria:

* Patient able to give written informed consent, - Presenting a major depressive episode defined according to DSM V criteria, - Presenting a MADRS score ≥ 20 - Able to understand all study procedures and follow-up

Exclusion Criteria:

* - Inability to wear the wearable monitor for the duration of the study (6 months)
* Patient with a severe medical condition at the discretion of the investigator (neurological, rheumatological, etc.)
* Resistant depression
* Chronic depression, dysthymia
* Depression with psychotic features not congruent with mood, schizophrenia disorder
* Depression with catatonic features
* Substance use disorder in the last 6 months
* Extreme sports during the conduct of the study
* Pre-existing skin infection at the wearable monitor site
* Pregnant or lactating woman
* Participation in another drug or medical device study
* Inability to give informed consent

Where this trial is running

Bersée and 10 other locations

• 135 rue Nestor Longue Epee — Bersée, France (Not_yet_recruiting)
• 203 rue de la Motte — Bersée, France (Recruiting)
• APPT 22 Residence les Tilleuls — Dax, France (Recruiting)
• 2 boulevard Winston Churchill — Dijon, France (Not_yet_recruiting)
• 2 boulevard Winston Churchill — Dijon, France (Not_yet_recruiting)
• Clinique Lyon Lumiere — Meyzieu, France (Not_yet_recruiting)
• 22 rue Jacques Boutrolles — Mont-Saint-Aignan, France (Recruiting)
• 19 rue de la Liberté — Nice, France (Not_yet_recruiting)
• 119 rue de la Pompe — Paris, France (Recruiting)
• 91 rue Caulaincpurt — Paris, France (Recruiting)
• 145 avenue des Minimes — Toulouse, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Sylvie Lafosse, Pharma D, MBA, INSEAD

Conditions Major Depressive Disorder