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

Sponsor

Digital For Mental Health (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05547035

Collaborator

(none)

200

Enrollment

Locations

Arm

69.8

Anticipated Duration (Months)

18.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Behavioral: Patient follow-up of depression	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 5, 2017

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
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 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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	135 rue Nestor Longue Epee	Bersée	France	59235
2	203 rue de la Motte	Bersée	France	59235
3	APPT 22 Residence les Tilleuls	Dax	France	40100
4	2 boulevard Winston Churchill	Dijon	France	21000.
5	2 boulevard Winston Churchill	Dijon	France	21000
6	Clinique Lyon Lumiere	Meyzieu	France	69330
7	22 rue Jacques Boutrolles	Mont-Saint-Aignan	France	76130
8	19 rue de la Liberté	Nice	France	06000
9	119 rue de la Pompe	Paris	France	75016
10	91 rue Caulaincpurt	Paris	France	75018
11	145 avenue des Minimes	Toulouse	France	31200

Sponsors and Collaborators

Digital For Mental Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Digital For Mental Health

ClinicalTrials.gov Identifier:

NCT05547035

Other Study ID Numbers:

2017-A00595-48
2017-A00595-48

First Posted:

Sep 21, 2022

Last Update Posted:

Sep 28, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depressive Disorder

Depressive Disorder, Major

Study Results

No Results Posted as of Sep 28, 2022