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

Last updated: March 4, 2024
Sponsor: Digital For Mental Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression (Adult And Geriatric)

Depression

Mood Disorders

Treatment

Patient follow-up of depression

Clinical Study ID

NCT05547035
2017-A00595-48
2017-A00595-48
  • Ages 18-65
  • All Genders

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Patient follow-up of depression
Phase:
Study Start date:
September 05, 2017
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • 135 rue Nestor Longue Epee

    Bersée, 59235
    France

    Site Not Available

  • 203 rue de la Motte

    Bersée, 59235
    France

    Active - Recruiting

  • APPT 22 Residence les Tilleuls

    Dax, 40100
    France

    Active - Recruiting

  • 2 boulevard Winston Churchill

    Dijon, 21000.
    France

    Site Not Available

  • Clinique Lyon Lumiere

    Meyzieu, 69330
    France

    Site Not Available

  • 22 rue Jacques Boutrolles

    Mont-Saint-Aignan, 76130
    France

    Active - Recruiting

  • 19 rue de la Liberté

    Nice, 06000
    France

    Site Not Available

  • 119 rue de la Pompe

    Paris, 75016
    France

    Active - Recruiting

  • 91 rue Caulaincpurt

    Paris, 75018
    France

    Active - Recruiting

  • 145 avenue des Minimes

    Toulouse, 31200
    France

    Site Not Available

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