Clinical trial NCT05547035: Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
Official title: Prospective, Multicenter Non-randomised, Open-label Study Evaluating the Correlation Between Physiological Data Measured by a Portable Sensor and Psychometric Assessment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Digital For Mental Health
Sponsor class: INDUSTRY
First posted: 2022-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 measured by photoplestimograph and the clinical evaluation performed by the physician, in patients suffering from major depression disorder.


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

Primary outcomes:
measure: Comparison of change in MADRS ( Montgomery-Asberg Depression Rating Scale) total score with physiological measurements.
timeFrame: Baseline, Month1, Month 2, Month 3, Month 4, Month 5, Month 6
measure: Comparison of change in HAD (Hospital Anxiety and Depression) total score with physiological measurements.
timeFrame: Baseline, Month1, Month 2, Month 3, Month 4, Month 5, Month 6
measure: Comparison of change in CGI (Clinical Global Impression) scale with physiological measurements.
timeFrame: Baseline, Month1, Month 2, Month 3, Month 4, Month 5, Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Bersée
country: France
facility: 135 rue Nestor Longue Epee
city: Bersée
country: France
facility: 203 rue de la Motte
city: Dax
country: France
facility: APPT 22 Residence les Tilleuls
city: Dijon
country: France
facility: 2 boulevard Winston Churchill
city: Dijon
country: France
facility: 2 boulevard Winston Churchill
city: Meyzieu
country: France
facility: Clinique Lyon Lumiere
city: Mont-Saint-Aignan
country: France
facility: 22 rue Jacques Boutrolles
city: Nice
country: France
facility: 19 rue de la Liberté
city: Paris
country: France
facility: 119 rue de la Pompe
city: Paris
country: France
facility: 91 rue Caulaincpurt
city: Toulouse
country: France
facility: 145 avenue des Minimes
Study officials:
References: