RecruitingNot ApplicableNCT06601140

Evaluation of the Concordance Between Measures Obtained by a Medical Device for Emotional Monitoring (EMOCARE) and the Patient Health Questionnaire (PHQ-9) Score in Patients With Mild to Severe Depressive Episode

Evaluation of the Concordance Between Measures Obtained by a Medical Device for Emotional Monitoring (EMOCARE) and the Patient Health Questionnaire (PHQ-9) Score in Patients With Mild to Severe Depressive Episode: Prospective, Multicentric, Comparative, Single Blind Clinical Investigation. EMC1 Study


Sponsor

Emobot

Enrollment

104 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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: 1. Install the software on a digital interface (smartphone, computer, etc.) and activate or deactivate it whenever they wish during the 6-week follow-up period. 2. Attend 2 scheduled appointments at the centre (a first appointment then a second 6 weeks later) to complete a series of questionnaires, being questioned by the doctor, and fill in other questionnaires on their own. 3. At home, answer questionnaires independently, 2 weeks and 4 weeks after the first appointment. 4. Receive a telephone call from the doctor 3 weeks after the first appointment to find out how the participants are feeling. 5. Keep a diary with the symptoms they have experienced, any medical consultations they have made, or changes in drug treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing readings from a wearable emotional monitoring device called EMOCARE to standard depression questionnaire scores, to see whether the device can accurately track the severity of depression in patients being treated as outpatients. **You may be eligible if...** - You are 18 or older - You have been diagnosed with unipolar major depression (not bipolar) and are being treated as an outpatient - Your depression score is at least 5 on the PHQ-9 questionnaire and at least 7 on the MADRS scale - You regularly use a smartphone or computer - You are able to read and understand French **You may NOT be eligible if...** - You are currently taking antipsychotic medications - You have an unstable medical condition that could interfere with the study - You have an active suicidal tendency or had a suicidal episode in the past 6 months - You have a borderline personality disorder diagnosis - You are a woman of childbearing age without effective contraception - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEMOCARE software

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.


Locations(11)

Private psychiatric practice

Agen, France

Private psychiatric pratice

Caen, France

Centre Psychothérapique de Nancy

Laxou, France

Private psychiatric practice

Maxéville, France

Private psychiatric practice

Nantes, France

Centre Hospitalier Universitaire de Nantes

Nantes, France

Private psychiatric practice

Paris, France

Private psychiatric practice

Reims, France

Centre hospitalier Guillaume Régnier

Rennes, France

Private psychiatric practice

Saint-Grégoire, France

Private psychiatric practice

Saint-Nazaire, France

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NCT06601140


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