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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02120-47 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Nîmes University Hospital | UNKNOWN |
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The aim of this study is to validate the EmoDTx as a digital tool for mood monitoring in adult patients with unipolar depression. The study is prospective, multicenter, and observational, with a single-arm approach. The device studied, EmoDTx, is a mood-monitoring application that analyzes patients' facial expressions to assess their emotional state. The study aims to compare mood scores obtained via EmoDTx with those of standard depression questionnaires (MADRS, PHQ-9, BDI-II, HAMD-17, QIDS-SR16). It will also provide information on how patients feel about the use of passive monitoring software (without the active involvement of the patient) and how the feedback sent to patients can help in their care.
Participants who agree to take part in the study, during a selection visit, will be able to:
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| Measure | Description | Time Frame |
|---|---|---|
| Change of score EmoDTx | Absolute difference | From baseline to 4 weeks |
| Change of score MADRS administrated by an investigator | Absolute difference | From baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of EmoDTx score | Between 2 weeks and 6 weeks | |
| Change of score PHQ-9 self reported | Between 2 weeks and 6 weeks | |
| Change of EmoDTx score |
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Inclusion criteria:
Exclusion criteria:
Patients hospitalized
Patients taking more than 75% of the maximal recommended daily dose of benzodiazepines
Patients taking more than 75% of the maximal recommended daily dose of antipsychotics
Patients taking more than 75% of the maximal recommended daily dose of neuroleptics
Patients who did not respond to 10 different pharmacological treatments
Patients who attempted suicide within the previous last 6 months and presenting with suicidal ideations
Patient presenting with bipolar disorders
Patients with a contra-indication to the device under evaluation:
Patients unable to read, write and understand French
Patients with no access to a smartphone or a computer with an internet connection
Patients who refuse to sign the Patient Informed Consent
Patients already participating in another interventional clinical study
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Adult patients suffering from mild to severe unipolar depression
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tanel PETELOT | Contact | +33 6 51 44 26 67 | contact@emobot.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet médical Sikorav - Chitic - Roux-Pertus | Recruiting | Changé | France | 53810 | France |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Between Baseline and 4 weeks, between Baseline and 8 weeks and between 4 weeks and 8 weeks |
| Change of HAMD-17 questionnaire administered by the investigator | Between Baseline and 4 weeks, between Baseline and 8 weeks and between 4 weeks and 8 weeks |
| Change of EmoDTx score | between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks |
| Change of score QIDS- SR16 self administrated | between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks |
| Change of score BDI-II self administrated | between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks |
| Score EmoDTx | At 4-weeks, at 8 week |
| Score MADRS administrated by the investigator | At 4-weeks, at 8 week |
| Score HAMD-17 administrated by the investigator | At 4-weeks, at 8 week |
| Score PHQ-9 self administrated | At 2-weeks and 6 weeks. |
| Score QIDS-SR16 self administrated | At 4-weeks and 8 weeks |
| To evaluate the ability of EmoDTx to predict changes in patient's mood earlier than the standard-of-care questionnaires HAMD-17, within 4 weeks and 8 weeks of follow-up. | Time to detection by EmoDTx of changes to depression severity symptoms within 4 weeks and 8 weeks of follow-up as compared to changes detected by standard-of-care questionnaires HAMD-17 Changes in depression severity |
| To evaluate the ability of EmoDTx to predict changes in patient's mood earlier than the standard-of-care questionnaires MADRS, within 4 weeks and 8 weeks of follow-up. | Time to detection by EmoDTx of changes to depression severity symptoms within 4 weeks and 8 weeks of follow-up as compared to changes detected by standard-of-care questionnaires MADRS Changes in depression severity |
| Score EQ-5D-5L | At 4 weeks and 8 weeks |
| Change of EmoDTx score when feedback is deactivated | From baseline to 4 weeks |
| Change of EmoDTx score when feedback is activated | From 4 weeks to 8 weeks |
| Acceptability of medical device questionnaire | A baseline and 8 weeks |
| Centre Hospitalier Universitaire de Nîmes | Recruiting | Nîmes | France | 3090 | France |
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