Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06601140

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

Led by Emobot · Updated on 2026-02-19

104

Participants Needed

11

Research Sites

100 weeks

Total Duration

On this page

Sponsors

E

Emobot

Lead Sponsor

N

Nantes University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient of both sexes aged 18 or over.
  • Outpatient with unipolar depression (major depressive disorder), regardless of episode duration.
  • PHQ-9 score of 5 or higher indicating a major depressive episode.
  • MADRS score of 7 or higher indicating a major depressive episode.
  • Regular user of a smartphone and/or computer.
  • Able to comply with study protocol as judged by the investigator.
  • Affiliated with or beneficiary of a social security scheme.
  • Provided informed consent after full information about the study.
  • Reads and understands French.
  • Completed clinical screening suitable for this study.
Not Eligible

You will not qualify if you...

  • Currently treated with antipsychotic drugs.
  • Presence of unstable medical conditions that could interfere with the study.
  • Unable to communicate or cooperate due to low mental capacity, language issues, or impaired brain function.
  • Active suicidal tendencies or suicidal episode within the last 6 months.
  • Diagnosed with borderline personality disorder.
  • Contraindication to any products under evaluation.
  • Woman of childbearing age without effective contraception.
  • Pregnant, birthing, or breastfeeding women.
  • Minors who are not legally emancipated.
  • Individuals legally incapacitated.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

Private psychiatric practice

Agen, France, 47000

Actively Recruiting

2

Private psychiatric pratice

Caen, France, 14000

Actively Recruiting

3

Centre Psychothérapique de Nancy

Laxou, France, 54521

Not Yet Recruiting

4

Private psychiatric practice

Maxéville, France, 54320

Terminated

5

Private psychiatric practice

Nantes, France, 44000

Actively Recruiting

6

Centre Hospitalier Universitaire de Nantes

Nantes, France, 44093

Not Yet Recruiting

7

Private psychiatric practice

Paris, France, 75013

Not Yet Recruiting

8

Private psychiatric practice

Reims, France, 51000

Not Yet Recruiting

9

Centre hospitalier Guillaume Régnier

Rennes, France, 35000

Actively Recruiting

10

Private psychiatric practice

Saint-Grégoire, France, 35760

Actively Recruiting

11

Private psychiatric practice

Saint-Nazaire, France, 44600

Actively Recruiting

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Research Team

T

Tanel PETELOT

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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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 | DecenTrialz