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

Major Depressive Disorder Clinical Trial

— MYND104  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547035
• Other study ID #: 2017-A00595-48
• Secondary ID: 2017-A00595-48
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Digital For Mental Health
• Contact: Sylvie Lafosse, Pharma D, MBA, INSEAD
• Phone: +33682232695
• Email: sylvie[@]myndblue.io
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
France	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Digital For Mental Health

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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