NCT06601140

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. 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. 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. 3.At home, answer questionnaires independently, 2 weeks and 4 weeks after the first appointment.
  4. 4.Receive a telephone call from the doctor 3 weeks after the first appointment to find out how the participants are feeling.
  5. 5.Keep a diary with the symptoms they have experienced, any medical consultations they have made, or changes in drug treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Mar 2025Feb 2027

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

March 5, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

September 9, 2024

Last Update Submit

February 18, 2026

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (2)

  • Change of scores EMOCARE

    Absolute difference

    From baseline to 6 weeks

  • Change of scores PHQ-9 self-administrered

    Absolute difference

    From baseline to 6 weeks

Secondary Outcomes (16)

  • Score EMOCARE

    At baseline, at 2 weeks, at 4 weeks

  • Change of EMOCARE score

    From baseline to 2 weeks, from baseline to 4 weeks

  • Score PHQ-9 self administered

    At baseline, at 2 weeks, at 4 weeks, at 6 weeks

  • Change of score PHQ-9 self administered

    From baseline to 2 weeks, From baseline to 4 weeks

  • Score PHQ-9 administered by an investigator

    At baseline, at 6 weeks

  • +11 more secondary outcomes

Study Arms (1)

EMOCARE

EXPERIMENTAL
Device: EMOCARE software

Interventions

EMOCARE softwareDEVICE

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.

EMOCARE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Private psychiatric practice

Agen, 47000, France

RECRUITING

Private psychiatric pratice

Caen, 14000, France

RECRUITING

Centre Psychothérapique de Nancy

Laxou, 54521, France

NOT YET RECRUITING

Private psychiatric practice

Maxéville, 54320, France

TERMINATED

Private psychiatric practice

Nantes, 44000, France

RECRUITING

Centre Hospitalier Universitaire de Nantes

Nantes, 44093, France

NOT YET RECRUITING

Private psychiatric practice

Paris, 75013, France

NOT YET RECRUITING

Private psychiatric practice

Reims, 51000, France

NOT YET RECRUITING

Centre hospitalier Guillaume Régnier

Rennes, 35000, France

RECRUITING

Private psychiatric practice

Saint-Grégoire, 35760, France

RECRUITING

Private psychiatric practice

Saint-Nazaire, 44600, France

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Central Study Contacts

Tanel PETELOT

CONTACT

+33 6 51 44 26 67tanel.petelot@emobot.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Patient health questionnaire - 9 (PHQ-9) and (Montgomery Asberg Depression Rating Scale) MADRS assessments will be performed by an investigator who doesn't know the score obtained with EMOCARE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

March 5, 2025

Primary Completion (Estimated)

February 4, 2027

Study Completion (Estimated)

February 4, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)