Evaluating an emotional monitoring device for depression assessment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Private psychiatric practice
  Agen, France Recruiting
• Private psychiatric pratice
  Caen, France Recruiting
• Private psychiatric practice
  Nantes, France 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.