Actively Recruiting
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
Eligibility Criteria
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.
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
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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
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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