Evaluating an emotional monitoring device for depression assessment
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
This study is testing a new emotional monitoring app to see if it can give reliable results for people with mild to moderate depression compared to traditional questionnaires.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emobot Industry-sponsored |
| Locations | 11 sites (Agen and 10 other locations) |
| Trial ID | NCT06601140 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to assess the consistency of results obtained from the EMOCARE emotional monitoring software compared to traditional assessment tools like the PHQ-9 in patients with mild to moderate depressive episodes. Participants will install the software on their devices and provide feedback on their experience with passive monitoring. The study will compare EMOCARE's results with established questionnaires used in depression management, including MADRS, GAD-7, BDI-II, and EQ-5D-5L. The goal is to determine the reliability of EMOCARE and identify any medical issues participants may encounter while using it.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with mild to moderate major depressive disorder who are familiar with using smartphones or computers.
Not a fit: Patients currently being treated with antipsychotic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of emotional monitoring in patients with depression, leading to better management of their condition.
How similar studies have performed: While the approach of using digital monitoring tools is gaining traction, the specific application of EMOCARE in this context is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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. * 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 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
Where this trial is running
Agen and 10 other locations
- Private psychiatric practice — Agen, France (Recruiting)
- Private psychiatric pratice — Caen, France (Recruiting)
- Centre Psychothérapique de Nancy — Laxou, France (Not_yet_recruiting)
- Private psychiatric practice — Maxéville, France (Terminated)
- Private psychiatric practice — Nantes, France (Recruiting)
- Centre Hospitalier Universitaire de Nantes — Nantes, France (Not_yet_recruiting)
- Private psychiatric practice — Paris, France (Not_yet_recruiting)
- Private psychiatric practice — Reims, France (Not_yet_recruiting)
- Centre hospitalier Guillaume Régnier — Rennes, France (Recruiting)
- Private psychiatric practice — Saint-Grégoire, France (Recruiting)
- Private psychiatric practice — Saint-Nazaire, France (Recruiting)
Study contacts
- Study coordinator: Tanel PETELOT
- Email: tanel.petelot@emobot.fr
- Phone: +33 6 51 44 26 67
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.