Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders (MYND104)

Digital For Mental Health

Status: Enrolling

Conditions: Major Depressive Disorder

Treatments: Behavioral: Patient follow-up of depression

Study type: Interventional

Funder types: Industry

Identifiers

NCT05547035

2017-A00595-48 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Wearable monitor collected phydiological measurements

Experimental group

Description:

This is a single arm study with a wearable monitor that collects physiological measures (falling in the categories physical activity, heart rate, heart rate variability, breathing rate and sleep) 24/7 in ambulatory.

Treatment:

Behavioral: Patient follow-up of depression