Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
Prospective, Multicenter Non-randomised, Open-label Study Evaluating the Correlation Between Physiological Data Measured by a Portable Sensor and Psychometric Assessment
Digital For Mental Health
200 participants
Sep 5, 2017
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- 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 Criteria12
- \- 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
Interventions
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.
Locations(11)
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NCT05547035