Status:
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
Lead Sponsor:
Emobot
Collaborating Sponsors:
Nantes University Hospital
Private psychiatric practice, Saint-Nazaire
Conditions:
Major Depressive Disorder (MDD)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 4 2027
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06601140
Start Date
March 5 2025
End Date
February 4 2027
Last Update
January 9 2026
Active Locations (9)
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1
Private psychiatric practice
Agen, France, 47000
2
Private psychiatric pratice
Caen, France, 14000
3
Centre Psychothérapique de Nancy
Laxou, France, 54521
4
Private psychiatric practice
Maxéville, France, 54320