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

NCT06601140 · tracked via the Priya Life Science France tracker

Sponsor

Emobot

Phase

Not applicable

Started

2025-03-05

Last updated

2026-02-19

Condition(s) studied

Major Depressive Disorder (MDD)

Investigational drug(s) / intervention(s)

EMOCARE software

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Change of scores EMOCARE — From baseline to 6 weeks
Absolute difference
Change of scores PHQ-9 self-administrered — From baseline to 6 weeks
Absolute difference

Trial sites (11)

Facility	City	Region	Status
Private psychiatric practice	Agen	France	Recruiting
Private psychiatric pratice	Caen	France	Recruiting
Centre Psychothérapique de Nancy	Laxou	France	Not Yet Recruiting
Private psychiatric practice	Maxéville	France	Terminated
Private psychiatric practice	Nantes	France	Recruiting
Centre Hospitalier Universitaire de Nantes	Nantes	France	Not Yet Recruiting
Private psychiatric practice	Paris	France	Not Yet Recruiting
Private psychiatric practice	Reims	France	Not Yet Recruiting
Centre hospitalier Guillaume Régnier	Rennes	France	Recruiting
Private psychiatric practice	Saint-Grégoire	France	Recruiting
Private psychiatric practice	Saint-Nazaire	France	Recruiting

More Emobot trials in France

Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients Suffering From Unipolar Depression Recruiting

Other trials for the same condition

Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients Suffering From Unipolar Depression Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06601140 on ClinicalTrials.gov ↗ ← All trials in France