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

Not Applicable

Recruiting

• Conditions: Major Depressive Disorder

• Registration Number: NCT05547035
• Lead Sponsor: Digital For Mental Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-05
• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Comparison of change in CGI (Clinical Global Impression) scale with physiological measurements.	Baseline, Month1, Month 2, Month 3, Month 4, Month 5, Month 6	* Change in CGI scale and comparison with changes in physiological measurements such as activity, emotional arousal, heart rate, heart rate variability, breathing rate and sleep.; * The Clinical Global Impression Scale (CGI-s), is a widely administered clinician rated scale that assesses the subject overall illness severity and the degree of improvement from the initial assessment. Illness severity is rated on a 1-7 scale where 1 corresponds to "Normal, Not at All Ill", 2 is "Borderline Mentally Ill", the anchor for 3 is "Mildly Ill", the anchor for 4 is "Moderately Ill", 5 is "Markedly Ill", 6 is "Severely Ill", and 7 is "Among the Most Extremely Ill Patients".The degree of improvement is rated on a 1-7 scale where 1 corresponds to "Very Much Improved", 2 is "Much Improved", the anchor for 3 is "Minimally Improved", the anchor for 4 is "No Change", 5 is "Minimally Worse", 6 is "Much Worse", and 7 is "Very Much Worse".
Comparison of change in HAD (Hospital Anxiety and Depression) total score with physiological measurements.	Baseline, Month1, Month 2, Month 3, Month 4, Month 5, Month 6	* Change in Hospital Anxiety and Depression total score and comparison with changes in physiological measurements such as activity, emotional arousal, heart rate, heart rate variability, breathing rate and sleep.; * The Hospital Anxiety and Depression Scale used for measuring anxiety Scored on a scale of 0-21 (higher score more anxiety) and for measuring depression Scored on a scale of 0-21 (higher score more depression).
Comparison of change in MADRS ( Montgomery-Asberg Depression Rating Scale) total score with physiological measurements.	Baseline, Month1, Month 2, Month 3, Month 4, Month 5, Month 6	* Change in central rater Montgomery-Asberg Depression Rating Scale (MADRS) total score and comparison with changes in physiological measurements such as activity, emotional arousal, heart rate, heart rate variability, breathing rate and sleep.; * The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 (low severity of depressive symptoms) and 60 points (high severity of depressive symptoms), higher score indicating poorer health outcomes. The MADRS provides a measure of the overall level of depression.

Trial Locations

Locations (10)

135 rue Nestor Longue Epee; 🇫🇷 Bersée, France

203 rue de la Motte; 🇫🇷 Bersée, France

APPT 22 Residence les Tilleuls; 🇫🇷 Dax, France

2 boulevard Winston Churchill; 🇫🇷 Dijon, France

Clinique Lyon Lumiere; 🇫🇷 Meyzieu, France

22 rue Jacques Boutrolles; 🇫🇷 Mont-Saint-Aignan, France

19 rue de la Liberté; 🇫🇷 Nice, France

119 rue de la Pompe; 🇫🇷 Paris, France

91 rue Caulaincpurt; 🇫🇷 Paris, France

145 avenue des Minimes; 🇫🇷 Toulouse, France