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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-05

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Wearable monitor collected phydiological measurements

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.

Group Type EXPERIMENTAL

Patient follow-up of depression

Intervention Type BEHAVIORAL

All patients who agree to participate in the study are diagnosed by their GP/Psychiatrist with a diagnostic assessment instrument called DSM-5. Participants visit their GPs/Psychiatrists at baseline, month 1, month 2, month 3, month 4, month 5 and month 6. At each visit, the GPs/Psychiatrists:

* assess the depression severity by using MADRS scale
* assess the severity of illness at time of assessment compared with start of treatment by using CGI-S measures
* the patient complete the self-administered questionnaire of HAD scale that measures the symptoms of anxiety and depression.

Interventions

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Patient follow-up of depression

All patients who agree to participate in the study are diagnosed by their GP/Psychiatrist with a diagnostic assessment instrument called DSM-5. Participants visit their GPs/Psychiatrists at baseline, month 1, month 2, month 3, month 4, month 5 and month 6. At each visit, the GPs/Psychiatrists:

* assess the depression severity by using MADRS scale
* assess the severity of illness at time of assessment compared with start of treatment by using CGI-S measures
* the patient complete the self-administered questionnaire of HAD scale that measures the symptoms of anxiety and depression.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No