Status:
UNKNOWN
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
Lead Sponsor:
Digital For Mental Health
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
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
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05547035
Start Date
September 5 2017
End Date
June 30 2025
Last Update
March 5 2024
Active Locations (11)
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1
135 rue Nestor Longue Epee
Bersée, France, 59235
2
203 rue de la Motte
Bersée, France, 59235
3
APPT 22 Residence les Tilleuls
Dax, France, 40100
4
2 boulevard Winston Churchill
Dijon, France, 21000.