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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-05

Study Completion Date

2027-02-04

Brief Summary

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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:

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.

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Detailed Description

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Conditions

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Major Depressive Disorder (MDD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

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

Study Groups

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EMOCARE

Group Type EXPERIMENTAL

EMOCARE software

Intervention Type 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.

Interventions

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EMOCARE 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient of both sexes aged 18 or over.
* Outpatient with unipolar depression (regardless of the time of the episode) (major depressive disorder).
* Patient with an episode of major depression supported by PHQ-9 score greater than or equal to 5.
* Patient with an episode of major depression supported by MADRS score greater than or equal to 7.
* Patient accustomed to regular use of a smartphone and/or computer
* Patient who, in the opinion of the investigator, will comply with the requirements of the protocol.
* Patient affiliated to a social security scheme or beneficiary of such a scheme.
* Patient who has received full information about how the clinical investigation shall be conducted and has signed an informed consent form.
* Patient who reads and understands French.
* Patient who has undergone clinical screening adapted to the clinical investigation.

Exclusion Criteria

* Patient treated with antipsychotic drugs.
* Patient with an unstable pathology that could interfere with the study.
* Patient unable to communicate or cooperate with the investigator due to a low mental level, language difficulties or impaired cerebral function.
* Patient with an active suicidal tendency or patient who has had a suicidal episode in the last 6 months
* Patients with borderline personality disorders.
* Patient with a contra-indication to the product(s) under evaluation.
* Woman of childbearing age without effective contraception.
* Pregnant woman, birthing or breastfeeding mother
* Minor (not emancipated)
* Incapacitated person

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No