Major Depressive DisorderMYND104NCT05547035
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
A study testing Patient follow-up of depression in people with Major Depressive Disorder, run by Digital For Mental Health at 11 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Patient follow-up of depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 11 sitesFrance
- Study dates
- 5 Sep 2017to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Show all 12Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites, 11 recruiting
- Not yet recruiting
135 rue Nestor Longue Epee
Bersée, 59235
Laurie Vuylsteker, MD, 0320596616
- Recruiting
203 rue de la Motte
Bersée, 59235
Delsart Dominique, MD, 0320849732
- Recruiting
APPT 22 Residence les Tilleuls
Dax, 40100
Carbonniere Patrick, MD, 0558743300
- Not yet recruiting
2 boulevard Winston Churchill
Dijon, 21000.
François Arcos, MD, 0380787850
- Not yet recruiting
2 boulevard Winston Churchill
Dijon, 21000
Christophe Boisselier, MD, 03 80 78 78 50
- Not yet recruiting
Clinique Lyon Lumiere
Meyzieu, 69330
Alexandre Thoinet, MD, 0437443737
- Recruiting
22 rue Jacques Boutrolles
Mont-Saint-Aignan, 76130
Marc Martin, MD, 0235071206
- Not yet recruiting
19 rue de la Liberté
Nice, 06000
Muriel Sasia, MD, 0493884320
- Recruiting
119 rue de la Pompe
Paris, 75016
Geneviève Saint-Mard, MD, 0147273390
- Recruiting
91 rue Caulaincpurt
Paris, 75018
Véronique Marais-Morini, MD, 0142518457
- Not yet recruiting
145 avenue des Minimes
Toulouse, 31200
David Modavi, MD, 0561286228
About this study
Official title: 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Patient follow-up of depression
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient follow-up of depressionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Wearable monitor collected phydiological measurements | Experimental | 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. Receives: Behavioral: Patient follow-up of depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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".
Measured: Baseline, Month1, Month 2, Month 3, Month 4, Month 5, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start5 Sep 2017
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Digital For Mental Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547035
- Sponsor's protocol ID
- 2017-A00595-48
- Other IDs
- 2017-A00595-48
- Acronym
- MYND104
- Status last verified
- Mar 2024
- First submitted
- 1 Jul 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Non-randomised, Open-label Study Evaluating the Correlation Between Physiological Data Measured by a Portable Sensor and Psychometric Assessment
- ClinicalTrials.gov ID
- NCT05547035
- Acronym / sponsor ID
- MYND104 / 2017-A00595-48
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Digital For Mental HealthIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearable monitor collected phydiological measurements | Experimental | Behavioral: Patient follow-up of depressionThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (12 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient follow-up of depressionAll 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. | Behavioural | Wearable monitor collected phydiological measurements |
Primary outcome
Comparison of change in MADRS ( Montgomery-Asberg Depression Rating Scale) total score with physiological measurements.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient follow-up of depression in people with Major Depressive Disorder, run by Digital For Mental Health at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvie Lafosse, Pharma D, MBA, INSEAD (+33682232695, sylvie@myndblue.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of change in MADRS ( Montgomery-Asberg Depression Rating Scale) total score with physiological measurements. (time frame: Baseline, Month1, Month 2, Month 3, Month 4, Month 5, Month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.