Clinical trial 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 Moderate Depressive Episode
Official 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 Moderate Depressive Episode: Prospective, Multicentric, Comparative, Single Blind Clinical Investigation. EMC1 Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Lead sponsor: Emobot
Sponsor class: INDUSTRY
Collaborators: name: Rumb
name: Nantes University Hospital
name: Private psychiatric practice, Saint-Nazaire
name: Groupement Hospitalier Paul Guiraud, Villejuif
name: Centre Hospitalier Guillaume Régnier, RENNES
name: Centre de Psychothérapie Nancéen, Laxou
First posted: 2024-09-19
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The participant will continuously use the EMOCARE software during the 6 weeks of follow-up and will answer the questionnaires usually used on a regular basis over the same period.
Primary purpose: OTHER

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 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.


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

Primary outcomes:
measure: Change of scores EMOCARE
timeFrame: From baseline to 6 weeks
measure: Change of scores PHQ-9 self-administrered
timeFrame: From baseline to 6 weeks
Secondary outcomes:
measure: Score EMOCARE
timeFrame: At baseline, at 2 weeks, at 4 weeks
measure: Change of EMOCARE score
timeFrame: From baseline to 2 weeks, from baseline to 4 weeks
measure: Score PHQ-9 self administered
timeFrame: At baseline, at 2 weeks, at 4 weeks, at 6 weeks
measure: Change of score PHQ-9 self administered
timeFrame: From baseline to 2 weeks, From baseline to 4 weeks
measure: Score PHQ-9 administered by an investigator
timeFrame: At baseline, at 6 weeks
measure: Change of score PHQ-9 administered by an investigator
timeFrame: From baseline to 6 weeks
measure: Score MADRS administered by an investigator
timeFrame: At baseline, at 6 weeks
measure: Change of MADRS administered by an investigator
timeFrame: From baseline to 6 weeks
measure: Score BDI-II
timeFrame: At baseline, at 6 weeks
measure: Change of BDI-II
timeFrame: From baseline to 6 weeks
measure: Score BDI-II
timeFrame: At baseline, at 2 weeks, at 4 weeks, at 6 weeks
measure: Change of BDI-II
timeFrame: From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks
measure: EMOCARE operating time
timeFrame: From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks
measure: EQ-5D-5L
timeFrame: At baseline, at 6 weeks
measure: Number of patient with adverse event
timeFrame: At baseline, at 2 weeks, at 3 weeks, at 4 weeks, at 6 weeks
measure: Acceptability of medical device questionnaire
timeFrame: At baseline, at 6 weeks
Other outcomes:
Locations:
city: Laxou
country: France
facility: Centre Psychothérapique de Nancy
city: Maxéville
country: France
facility: Private psychiatric practice
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Rennes
country: France
facility: Centre hospitalier Guillaume Régnier
city: Saint Nazaire
country: France
facility: Private psychiatric practice
Study officials:
References: