Major Depressive Disorder (MDD)EMC1NCT06601140
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
A study testing EMOCARE software in people with Major Depressive Disorder (MDD), run by Emobot at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- EMOCARE software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 11 sitesFrance
- Study dates
- 5 Mar 2025to 4 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Woman of childbearing age without effective contraception.
- Pregnant woman, birthing or breastfeeding mother
- Minor (not emancipated)
- Incapacitated person
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 10 recruiting
- Recruiting
Private psychiatric practice
Agen, 47000
- Recruiting
Private psychiatric pratice
Caen, 14000
- Not yet recruiting
Centre Psychothérapique de Nancy
Laxou, 54521
Raymund SCHWAN, Professor
- Terminated
Private psychiatric practice
Maxéville, 54320
- Recruiting
Private psychiatric practice
Nantes, 44000
- Not yet recruiting
Centre Hospitalier Universitaire de Nantes
Nantes, 44093
- Not yet recruiting
Private psychiatric practice
Paris, 75013
- Not yet recruiting
Private psychiatric practice
Reims, 51000
- Recruiting
Centre hospitalier Guillaume Régnier
Rennes, 35000
- Recruiting
Private psychiatric practice
Saint-Grégoire, 35760
- Recruiting
Private psychiatric practice
Saint-Nazaire, 44600
About this study
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 Severe Depressive Episode: Prospective, Multicentric, Comparative, Single Blind Clinical Investigation. EMC1 Study
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?
Read more
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:
- 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.
- 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.
- At home, answer questionnaires independently, 2 weeks and 4 weeks after the first appointment.
- Receive a telephone call from the doctor 3 weeks after the first appointment to find out how the participants are feeling.
- Keep a diary with the symptoms they have experienced, any medical consultations they have made, or changes in drug treatment.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- EMOCARE software
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| EMOCARE | Experimental | Not described Receives: Device: EMOCARE software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of scores EMOCARE
Absolute difference
Measured: From baseline to 6 weeks
Change of scores PHQ-9 self-administrered
Absolute difference
Measured: From baseline to 6 weeks
Secondary outcomes (16)
Score EMOCARE
Measured: At baseline, at 2 weeks, at 4 weeks
Change of EMOCARE score
Measured: From baseline to 2 weeks, from baseline to 4 weeks
Score PHQ-9 self administered
Measured: At baseline, at 2 weeks, at 4 weeks, at 6 weeks
Change of score PHQ-9 self administered
Measured: From baseline to 2 weeks, From baseline to 4 weeks
Score PHQ-9 administered by an investigator
Measured: At baseline, at 6 weeks
Change of score PHQ-9 administered by an investigator
Measured: From baseline to 6 weeks
Score MADRS administered by an investigator
Measured: At baseline, at 6 weeks
Change of MADRS administered by an investigator
Measured: From baseline to 6 weeks
Score BDI-II
Measured: At baseline, at 6 weeks
Change of BDI-II
Measured: From baseline to 6 weeks
Score BDI-II
Measured: At baseline, at 2 weeks, at 4 weeks, at 6 weeks
Change of BDI-II
Measured: From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks
EMOCARE operating time
Measured: From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks
EQ-5D-5L
Measured: At baseline, at 6 weeks
Number of patient with adverse event
Measured: At baseline, at 2 weeks, at 3 weeks, at 4 weeks, at 6 weeks
Acceptability of medical device questionnaire
Measured: At baseline, at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Mar 2025
- Primary completion4 Feb 2027 (estimated)
- Study completion4 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emobot
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nantes University Hospital, Private psychiatric practice, Saint-Nazaire, Groupement Hospitalier Paul Guiraud, Villejuif, Centre Hospitalier Guillaume Régnier, RENNES, Centre de Psychothérapie Nancéen, Laxou, Rumb, Private psychiatric pratice, Agen, Private psychiatric pratice, Caen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601140
- Sponsor's protocol ID
- EB-EMC1-2024
- Other IDs
- 2024-A01487-40
- Acronym
- EMC1
- Status last verified
- Feb 2026
- First submitted
- 9 Sep 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Severe Depressive Episode: Prospective, Multicentric, Comparative, Single Blind Clinical Investigation. EMC1 Study
- ClinicalTrials.gov ID
- NCT06601140
- Acronym / sponsor ID
- EMC1 / EB-EMC1-2024
- Conditions
- Major Depressive Disorder (MDD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- EmobotIndustry (pharma, biotech, devices)
- Collaborators
- Nantes University Hospital, Private psychiatric practice, Saint-Nazaire, Groupement Hospitalier Paul Guiraud, Villejuif, Centre Hospitalier Guillaume Régnier, RENNES, Centre de Psychothérapie Nancéen, Laxou, Rumb, Private psychiatric pratice, Agen, Private psychiatric pratice, Caen
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 4 Feb 2027 (estimated)
- Study completion
- 4 Feb 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- At home, answer questionnaires independently, 2 weeks and 4 weeks after the first appointment.
- Receive a telephone call from the doctor 3 weeks after the first appointment to find out how the participants are feeling.
- Keep a diary with the symptoms they have experienced, any medical consultations they have made, or changes in drug treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| EMOCARE | Experimental | Device: EMOCARE software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMOCARE softwareUse of the EMOCARE software on the digital device of participant (smartphone, computer, etc.). The participant can activate and deactivate the software whenever he wishes. | Device | EMOCARE |
Primary outcome
Change of scores EMOCARE
Time frame: From baseline to 6 weeks
Absolute difference
Change of scores PHQ-9 self-administrered
Time frame: From baseline to 6 weeks
Absolute difference
16 secondary outcomes
Score EMOCARE
Time frame: At baseline, at 2 weeks, at 4 weeks
Change of EMOCARE score
Time frame: From baseline to 2 weeks, from baseline to 4 weeks
Score PHQ-9 self administered
Time frame: At baseline, at 2 weeks, at 4 weeks, at 6 weeks
Change of score PHQ-9 self administered
Time frame: From baseline to 2 weeks, From baseline to 4 weeks
Score PHQ-9 administered by an investigator
Time frame: At baseline, at 6 weeks
Change of score PHQ-9 administered by an investigator
Time frame: From baseline to 6 weeks
Score MADRS administered by an investigator
Time frame: At baseline, at 6 weeks
Change of MADRS administered by an investigator
Time frame: From baseline to 6 weeks
Score BDI-II
Time frame: At baseline, at 6 weeks
Change of BDI-II
Time frame: From baseline to 6 weeks
Score BDI-II
Time frame: At baseline, at 2 weeks, at 4 weeks, at 6 weeks
Change of BDI-II
Time frame: From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks
EMOCARE operating time
Time frame: From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks
EQ-5D-5L
Time frame: At baseline, at 6 weeks
Number of patient with adverse event
Time frame: At baseline, at 2 weeks, at 3 weeks, at 4 weeks, at 6 weeks
Acceptability of medical device questionnaire
Time frame: At baseline, at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMOCARE software in people with Major Depressive Disorder (MDD), run by Emobot at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tanel PETELOT (+33 6 51 44 26 67, tanel.petelot@emobot.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of scores EMOCARE (time frame: From baseline to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.