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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01487-40 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Nantes University Hospital | OTHER |
| Private psychiatric practice, Saint-Nazaire | UNKNOWN |
| Groupement Hospitalier Paul Guiraud, Villejuif | UNKNOWN |
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The aim of this clinical investigation is to find out whether the EMOCARE emotional monitoring software provides consistent results compared with the tools available for assessing the emotional state of patients suffering from mild to moderately severe depressive episod. It will also provide information on how patients feel about the use of passive monitoring software (without the active involvement of patient). The main questions it aims to answer are as follows:
Does EMOCARE provide consistent results compared with tools already used in current practice? What are the medical problems encountered by participants when using EMOCARE?
The researchers will compare EMCOCARE to various questionnaires usually used in the management of patients suffering from depression (PHQ-9, MADRS, GAD-7, BDI-II, EQ-5D-5L).
Participants who agree to take part in the study, during a selection visit, will be able to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMOCARE | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMOCARE software | Device | Use of the EMOCARE software on the digital device of participant (smartphone, computer, etc.). The participant can activate and deactivate the software whenever he wishes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of scores EMOCARE | Absolute difference | From baseline to 6 weeks |
| Change of scores PHQ-9 self-administrered | Absolute difference | From baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Score EMOCARE | At baseline, at 2 weeks, at 4 weeks | |
| Change of EMOCARE score | From baseline to 2 weeks, from baseline to 4 weeks | |
| Score PHQ-9 self administered |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tanel PETELOT | Contact | +33 6 51 44 26 67 | tanel.petelot@emobot.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private psychiatric practice | Recruiting | Agen | 47000 | France | ||
| Private psychiatric pratice |
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| Centre Hospitalier Guillaume Régnier, RENNES |
| UNKNOWN |
| Centre de Psychothérapie Nancéen, Laxou | UNKNOWN |
| Rumb | UNKNOWN |
| Private psychiatric pratice, Agen | UNKNOWN |
| Private psychiatric pratice, Caen | UNKNOWN |
The participant will continuously use the EMOCARE software during the 6 weeks of follow-up and will answer the questionnaires usually used on a regular basis over the same period.
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Patient health questionnaire - 9 (PHQ-9) and (Montgomery Asberg Depression Rating Scale) MADRS assessments will be performed by an investigator who doesn't know the score obtained with EMOCARE
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| At baseline, at 2 weeks, at 4 weeks, at 6 weeks |
| Change of score PHQ-9 self administered | From baseline to 2 weeks, From baseline to 4 weeks |
| Score PHQ-9 administered by an investigator | At baseline, at 6 weeks |
| Change of score PHQ-9 administered by an investigator | From baseline to 6 weeks |
| Score MADRS administered by an investigator | At baseline, at 6 weeks |
| Change of MADRS administered by an investigator | From baseline to 6 weeks |
| Score BDI-II | At baseline, at 6 weeks |
| Change of BDI-II | From baseline to 6 weeks |
| Score BDI-II | At baseline, at 2 weeks, at 4 weeks, at 6 weeks |
| Change of BDI-II | From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks |
| EMOCARE operating time | From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks |
| EQ-5D-5L | At baseline, at 6 weeks |
| Number of patient with adverse event | At baseline, at 2 weeks, at 3 weeks, at 4 weeks, at 6 weeks |
| Acceptability of medical device questionnaire | At baseline, at 6 weeks |
| Recruiting |
| Caen |
| 14000 |
| France |
| Centre Psychothérapique de Nancy | Not yet recruiting | Laxou | 54521 | France |
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| Private psychiatric practice | Terminated | Maxéville | 54320 | France |
| Private psychiatric practice | Recruiting | Nantes | 44000 | France |
| Centre Hospitalier Universitaire de Nantes | Not yet recruiting | Nantes | 44093 | France |
| Private psychiatric practice | Not yet recruiting | Paris | 75013 | France |
| Private psychiatric practice | Not yet recruiting | Reims | 51000 | France |
| Centre hospitalier Guillaume Régnier | Recruiting | Rennes | 35000 | France |
| Private psychiatric practice | Recruiting | Saint-Grégoire | 35760 | France |
| Private psychiatric practice | Recruiting | Saint-Nazaire | 44600 | France |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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