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 Moderate Depressive Episode

Launched by EMOBOT · Sep 15, 2024

Keywords

ClinConnect Summary

The EMOCARE clinical trial is studying a new emotional monitoring software designed to help people with mild to moderate depression. The main goal is to see if the results from this software match those from traditional questionnaires used to assess depression, like the PHQ-9. This trial will also gather feedback from participants about their experiences using the software. By comparing EMOCARE with these established tools, researchers hope to learn if it can be a reliable option for monitoring emotional health in patients.

To participate, individuals need to be at least 18 years old, have a diagnosis of major depressive disorder, and be comfortable using a smartphone or computer. Participants will install the EMOCARE software on their devices and will have regular check-ins with a doctor over a six-week period. This includes completing questionnaires, attending two in-person appointments, and keeping a diary of their symptoms. It's important to note that certain individuals, such as those currently taking antipsychotic medications or with active suicidal thoughts, will not be eligible for this study.

Gender

ALL

Eligibility criteria

• 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 and strictly less than 20.
• • Patient with an episode of major depression supported by MADRS score greater than or equal to 7 and strictly less than 35.
• • 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