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

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patient follow-up of depression
Sponsored by
Digital For Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • 135 rue Nestor Longue Epee
  • 203 rue de la MotteRecruiting
  • APPT 22 Residence les TilleulsRecruiting
  • 2 boulevard Winston Churchill
  • 2 boulevard Winston Churchill
  • Clinique Lyon Lumiere
  • 22 rue Jacques BoutrollesRecruiting
  • 19 rue de la Liberté
  • 119 rue de la PompeRecruiting
  • 91 rue CaulaincpurtRecruiting
  • 145 avenue des Minimes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Wearable monitor collected phydiological measurements

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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).
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".

Secondary Outcome Measures

Full Information

First Posted
July 1, 2022
Last Updated
September 22, 2022
Sponsor
Digital For Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT05547035
Brief Title
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
Acronym
MYND104
Official Title
Prospective, Multicenter Non-randomised, Open-label Study Evaluating the Correlation Between Physiological Data Measured by a Portable Sensor and Psychometric Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Digital For Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wearable monitor collected phydiological measurements
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient follow-up of depression
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of change in MADRS ( Montgomery-Asberg Depression Rating Scale) total score with physiological measurements.
Description
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.
Time Frame
Baseline, Month1, Month 2, Month 3, Month 4, Month 5, Month 6
Title
Comparison of change in HAD (Hospital Anxiety and Depression) total score with physiological measurements.
Description
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).
Time Frame
Baseline, Month1, Month 2, Month 3, Month 4, Month 5, Month 6
Title
Comparison of change in CGI (Clinical Global Impression) scale with physiological measurements.
Description
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".
Time Frame
Baseline, Month1, Month 2, Month 3, Month 4, Month 5, Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvie Lafosse, Pharma D, MBA, INSEAD
Phone
+33682232695
Email
sylvie@myndblue.io
Facility Information:
Facility Name
135 rue Nestor Longue Epee
City
Bersée
ZIP/Postal Code
59235
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurie Vuylsteker, MD
Phone
0320596616
Facility Name
203 rue de la Motte
City
Bersée
ZIP/Postal Code
59235
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delsart Dominique, MD
Phone
0320849732
Facility Name
APPT 22 Residence les Tilleuls
City
Dax
ZIP/Postal Code
40100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carbonniere Patrick, MD
Phone
0558743300
Facility Name
2 boulevard Winston Churchill
City
Dijon
ZIP/Postal Code
21000.
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Arcos, MD
Phone
0380787850
Facility Name
2 boulevard Winston Churchill
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Boisselier, MD
Phone
03 80 78 78 50
Facility Name
Clinique Lyon Lumiere
City
Meyzieu
ZIP/Postal Code
69330
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Thoinet, MD
Phone
0437443737
Facility Name
22 rue Jacques Boutrolles
City
Mont-Saint-Aignan
ZIP/Postal Code
76130
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Martin, MD
Phone
0235071206
Facility Name
19 rue de la Liberté
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muriel Sasia, MD
Phone
0493884320
Facility Name
119 rue de la Pompe
City
Paris
ZIP/Postal Code
75016
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geneviève Saint-Mard, MD
Phone
0147273390
Facility Name
91 rue Caulaincpurt
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique Marais-Morini, MD
Phone
0142518457
Facility Name
145 avenue des Minimes
City
Toulouse
ZIP/Postal Code
31200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Modavi, MD
Phone
0561286228

12. IPD Sharing Statement

Learn more about this trial

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

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