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NCT Number: NCT06601140

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

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:

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private psychiatric practice, Agen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMOCARE software

Device

Use of the EMOCARE software on the digital device of participant (smartphone, computer, etc.). The participant can activate and deactivate the software whenever he wishes.

Primary outcomes

  1. Change of scores EMOCARE

    Time frame: From baseline to 6 weeks

    Absolute difference

  2. Change of scores PHQ-9 self-administrered

    Time frame: From baseline to 6 weeks

    Absolute difference

Secondary outcomes

  1. Score EMOCARE

    Time frame: At baseline, at 2 weeks, at 4 weeks

  2. Change of EMOCARE score

    Time frame: From baseline to 2 weeks, from baseline to 4 weeks

  3. Score PHQ-9 self administered

    Time frame: At baseline, at 2 weeks, at 4 weeks, at 6 weeks

  4. Change of score PHQ-9 self administered

    Time frame: From baseline to 2 weeks, From baseline to 4 weeks

  5. Score PHQ-9 administered by an investigator

    Time frame: At baseline, at 6 weeks

  6. Change of score PHQ-9 administered by an investigator

    Time frame: From baseline to 6 weeks

  7. Score MADRS administered by an investigator

    Time frame: At baseline, at 6 weeks

  8. Change of MADRS administered by an investigator

    Time frame: From baseline to 6 weeks

  9. Score BDI-II

    Time frame: At baseline, at 6 weeks

  10. Change of BDI-II

    Time frame: From baseline to 6 weeks

  11. Score BDI-II

    Time frame: At baseline, at 2 weeks, at 4 weeks, at 6 weeks

  12. Change of BDI-II

    Time frame: From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks

  13. EMOCARE operating time

    Time frame: From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks

  14. EQ-5D-5L

    Time frame: At baseline, at 6 weeks

  15. Number of patient with adverse event

    Time frame: At baseline, at 2 weeks, at 3 weeks, at 4 weeks, at 6 weeks

  16. Acceptability of medical device questionnaire

    Time frame: At baseline, at 6 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Tanel PETELOT

CONTACT

[email protected]

+33 6 51 44 26 67

Sponsors and collaborators

Lead sponsor

Emobot

Industry

Collaborators

  • Centre Hospitalier Guillaume Régnier, RENNES
  • Centre de Psychothérapie Nancéen, Laxou
  • Groupement Hospitalier Paul Guiraud, Villejuif
  • Nantes University Hospital
  • Private psychiatric practice, Saint-Nazaire
  • Private psychiatric pratice, Agen
  • Private psychiatric pratice, Caen
  • Rumb

Registry information

Official study 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

Acronym: EMC1

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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