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

Prospective, Multicenter Non-randomised, Open-label Study Evaluating the Correlation Between Physiological Data Measured by a Portable Sensor and Psychometric Assessment

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.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Patient follow-up of depression

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sylvie Lafosse, Pharma D, MBA, INSEAD; Phone Number: +33682232695; Email: sylvie@myndblue.io

Study Locations

• France
  • Bersée, France, 59235
    • Not yet recruiting
    • 135 rue Nestor Longue Epee
    • Contact: Laurie Vuylsteker, MD; Phone Number: 0320596616
  • Bersée, France, 59235
    • Recruiting
    • 203 rue de la Motte
    • Contact: Delsart Dominique, MD; Phone Number: 0320849732
  • Dax, France, 40100
    • Recruiting
    • APPT 22 Residence les Tilleuls
    • Contact: Carbonniere Patrick, MD; Phone Number: 0558743300
  • Dijon, France, 21000.
    • Not yet recruiting
    • 2 boulevard Winston Churchill
    • Contact: François Arcos, MD; Phone Number: 0380787850
  • Dijon, France, 21000
    • Not yet recruiting
    • 2 boulevard Winston Churchill
    • Contact: Christophe Boisselier, MD; Phone Number: 03 80 78 78 50
  • Meyzieu, France, 69330
    • Not yet recruiting
    • Clinique Lyon Lumiere
    • Contact: Alexandre Thoinet, MD; Phone Number: 0437443737
  • Mont-Saint-Aignan, France, 76130
    • Recruiting
    • 22 rue Jacques Boutrolles
    • Contact: Marc Martin, MD; Phone Number: 0235071206
  • Nice, France, 06000
    • Not yet recruiting
    • 19 rue de la Liberté
    • Contact: Muriel Sasia, MD; Phone Number: 0493884320
  • Paris, France, 75016
    • Recruiting
    • 119 rue de la Pompe
    • Contact: Geneviève Saint-Mard, MD; Phone Number: 0147273390
  • Paris, France, 75018
    • Recruiting
    • 91 rue Caulaincpurt
    • Contact: Véronique Marais-Morini, MD; Phone Number: 0142518457
  • Toulouse, France, 31200
    • Not yet recruiting
    • 145 avenue des Minimes
    • Contact: David Modavi, MD; Phone Number: 0561286228

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of change in MADRS ( Montgomery-Asberg Depression Rating Scale) total score with physiological measurements.	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.	Baseline, Month1, Month 2, Month 3, Month 4, Month 5, Month 6
Comparison of change in HAD (Hospital Anxiety and Depression) total score with physiological measurements.	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).	Baseline, Month1, Month 2, Month 3, Month 4, Month 5, Month 6
Comparison of change in CGI (Clinical Global Impression) scale with physiological measurements.	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".	Baseline, Month1, Month 2, Month 3, Month 4, Month 5, Month 6

Collaborators and Investigators

• Sponsor: Digital For Mental Health

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 2017-A00595-48 (Other Identifier: French Competent Authority(ANSM) reference number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No