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Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders

Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders

Recruiting
18-65 years
All
Phase N/A

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Overview

To evaluate, over a period of six months, the links between physiological data collected such as electrodermal activity (or Galvanic Skin Response), motor activity measured by accelerometer, heartbeat measured by photoplestimograph and the clinical evaluation performed by the physician, in patients suffering from major depression disorder.

Eligibility

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

Study details
    Major Depressive Disorder

NCT05547035

Digital For Mental Health

14 October 2025

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