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Taking people in FranceNo phase

Compares an emotional monitoring app with standard depression questionnaires

Tests the EMOCARE software against usual questionnaires in adults with depression.

Key facts

Who runs it
Emobot
Where
Agen, Caen, Laxou, Maxéville, Nantes, Paris, Reims, Rennes, Saint-Grégoire, and Saint-Nazaire, FranceSee the 11 sites
Trial code
Registry 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
Status
Recruiting
People taking part
104 people, planned
Started
5 Mar 2025
Expected to end
4 Feb 2027
Type of study
Interventional
Treatments tested
  • EMOCARE software
Record updated
19 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with major depression who are treated as outpatients and use a smartphone or computer regularly. It tests whether the EMOCARE software gives results consistent with depression questionnaires.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Unipolar depression (major depressive disorder), mild to severe, with a PHQ-9 score of 5 or more and a MADRS score of 7 or more.
Earlier treatment
People treated with antipsychotic drugs cannot join.

Main reasons for not taking part

  • Treated with antipsychotic drugs
  • Active suicidal tendency, or a suicidal episode in the last 6 months
  • Borderline personality disorder
  • Pregnant, giving birth or breastfeeding
  • Unstable illness that could interfere with the study

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patient treated with antipsychotic drugs
  • Patients with borderline personality disorders
  • Woman of childbearing age without effective contraception
  • 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
  • Patient with a contra-indication to the product(s) under evaluation
  • Pregnant woman, birthing or breastfeeding mother
  • Minor (not emancipated)
  • Incapacitated person

Where in France

  • Private psychiatric practiceAgen, FranceContact: Tanel PETELOTTaking people
  • Private psychiatric praticeCaen, FranceContact: Tanel PETELOTTaking people
  • Centre Psychothérapique de NancyLaxou, FranceContact: Raymund SCHWAN, Professor (principal investigator)Not yet recruiting
  • Private psychiatric practiceMaxéville, FranceContact: Tanel PETELOTNo longer taking part
  • Centre Hospitalier Universitaire de NantesNantes, FranceContact: Tanel PETELOTNot yet recruiting
  • Private psychiatric practiceNantes, FranceContact: Tanel PETELOTTaking people
  • Private psychiatric practiceParis, FranceContact: Tanel PETELOTNot yet recruiting
  • Private psychiatric practiceReims, FranceContact: Tanel PETELOTNot yet recruiting
  • Centre hospitalier Guillaume RégnierRennes, FranceContact: Tanel PETELOTTaking people
  • Private psychiatric practiceSaint-Grégoire, FranceContact: Tanel PETELOTTaking people
  • Private psychiatric practiceSaint-Nazaire, FranceContact: Tanel PETELOTTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The group in the trial

  • EMOCARETreatment being tested

    Treatment: EMOCARE software

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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: Prospective, Multicentric, Comparative, Single Blind Clinical Investigation. EMC1 Study
Plain-language title
Compares an emotional monitoring app with standard depression questionnairesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
19 February 2026