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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A00595-48 | Other Identifier | French Competent Authority(ANSM) reference number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient follow-up of depression | Behavioral | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Comparison of change in CGI (Clinical Global Impression) scale with physiological measurements. |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sylvie Lafosse, Pharma D, MBA, INSEAD | Contact | +33682232695 | sylvie@myndblue.io |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 135 rue Nestor Longue Epee | Not yet recruiting | Bersée | 59235 | France |
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| Baseline, Month1, Month 2, Month 3, Month 4, Month 5, Month 6 |
| 203 rue de la Motte | Recruiting | Bersée | 59235 | France |
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| APPT 22 Residence les Tilleuls | Recruiting | Dax | 40100 | France |
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| 2 boulevard Winston Churchill | Not yet recruiting | Dijon | 21000. | France |
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| 2 boulevard Winston Churchill | Not yet recruiting | Dijon | 21000 | France |
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| Clinique Lyon Lumiere | Not yet recruiting | Meyzieu | 69330 | France |
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| 22 rue Jacques Boutrolles | Recruiting | Mont-Saint-Aignan | 76130 | France |
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| 19 rue de la Liberté | Not yet recruiting | Nice | 06000 | France |
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| 119 rue de la Pompe | Recruiting | Paris | 75016 | France |
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| 91 rue Caulaincpurt | Recruiting | Paris | 75018 | France |
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| 145 avenue des Minimes | Not yet recruiting | Toulouse | 31200 | France |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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