Unipolar DepressionEMC2FRNCT06860165
Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients Suffering From Unipolar Depression
An observational study of Unipolar Depression and Major Depressive Disorder (MDD), run by Emobot at 2 sites in France.
Trial summary
The aim of this study is to validate the EmoDTx as a digital tool for mood monitoring in adult patients with unipolar depression. The study is prospective, multicenter, and observational, with a single-arm approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unipolar Depression, Major Depressive Disorder (MDD), Depression
- How many people
- 98 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jul 2025to 9 Dec 2025
- Phase
- Observational
- 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
Study population: Adult patients suffering from mild to severe unipolar depression
Who may be able to join
- Outpatients diagnosed with mild to severe unipolar disorder
- Age ≥ 18 years old
- Patients willing and able to participate (i.e willing to use the EmoDTx App and having the necessary technical equipment to use it)
- Patients who read, write and understand French
- Patients having signed the Patient Informed Consent
Who cannot join
- Patients hospitalized
- Patients taking more than 75% of the maximal recommended daily dose of benzodiazepines
- Patients taking more than 75% of the maximal recommended daily dose of antipsychotics
- Patients taking more than 75% of the maximal recommended daily dose of neuroleptics
- Patients who did not respond to 10 different pharmacological treatments
- Patients who attempted suicide within the previous last 6 months and presenting with suicidal ideations
Show all 17Show fewer
- Patient presenting with bipolar disorders
- Patients with a contra-indication to the device under evaluation:
- Severe depression requiring hospitalization
- Schizophrenic disorders according to DSM 5 classification
- Major neurocognitive disorders according to DSM 5 classification
- Illiteracy
- Subject hospitalized in a healthcare or social institution for reasons other than biomedical research or is deprived of freedom by administrative or judicial decision or is placed under guardianship
- Patients unable to read, write and understand French
- Patients with no access to a smartphone or a computer with an internet connection
- Patients who refuse to sign the Patient Informed Consent
- Patients already participating in another interventional clinical study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Cabinet médical Sikorav - Chitic - Roux-Pertus
Changé, France, 53810
Clara Roux-Pertus, 02 43 53 32 80, clara.roux.pertus@gmail.com
- Recruiting
Centre Hospitalier Universitaire de Nîmes
Nîmes, France, 3090
Fabrice Boulet, 04 66 68 34 26, fabrice.boulet@chu-nimes.fr
About this study
Official title: Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients With Unipolar Depression: An Observational Study Against Standard Depression Assessment Questionnaires
The aim of this study is to validate the EmoDTx as a digital tool for mood monitoring in adult patients with unipolar depression. The study is prospective, multicenter, and observational, with a single-arm approach. The device studied, EmoDTx, is a mood-monitoring application that analyzes patients' facial expressions to assess their emotional state. The study aims to compare mood scores obtained via EmoDTx with those of standard depression questionnaires (MADRS, PHQ-9, BDI-II, HAMD-17, QIDS-SR16). It will also provide information on how patients feel about the use of passive monitoring software (without the active involvement of the patient) and how the feedback sent to patients can help in their care.
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 8-week follow-up period.
- Attend scheduled appointments at the center (a first appointment, then a second 4 weeks later, and a final at 8 weeks) to complete a series of questionnaires, be questioned by the doctor, and fill in other questionnaires on their own.
- At home, answer questionnaires independently, 2 weeks and 6 weeks after the first appointment.
- The application's feedback will be deactivated during the first 4 weeks and then reactivated during the final 4 weeks.
- In parallel, an ancillary study will be conducted on 16 patients enrolled in EMC2FR who accepted and performed the video recording of their structured clinical interview following SCID-5-CV at baseline and 4 weeks.
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Major, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of score EmoDTx
Absolute difference
Measured: From baseline to 4 weeks
Change of score MADRS administrated by an investigator
Absolute difference
Measured: From baseline to 4 weeks
Secondary outcomes (18)
Change of EmoDTx score
Measured: Between 2 weeks and 6 weeks
Change of score PHQ-9 self reported
Measured: Between 2 weeks and 6 weeks
Change of EmoDTx score
Measured: Between Baseline and 4 weeks, between Baseline and 8 weeks and between 4 weeks and 8 weeks
Change of HAMD-17 questionnaire administered by the investigator
Measured: Between Baseline and 4 weeks, between Baseline and 8 weeks and between 4 weeks and 8 weeks
Change of EmoDTx score
Measured: between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks
Change of score QIDS- SR16 self administrated
Measured: between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks
Change of score BDI-II self administrated
Measured: between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks
Score EmoDTx
Measured: At 4-weeks, at 8 week
Score MADRS administrated by the investigator
Measured: At 4-weeks, at 8 week
Score HAMD-17 administrated by the investigator
Measured: At 4-weeks, at 8 week
Score PHQ-9 self administrated
Measured: At 2-weeks and 6 weeks.
Score QIDS-SR16 self administrated
Measured: At 4-weeks and 8 weeks
To evaluate the ability of EmoDTx to predict changes in patient's mood earlier than the standard-of-care questionnaires HAMD-17, within 4 weeks and 8 weeks of follow-up.
Measured: Time to detection by EmoDTx of changes to depression severity symptoms within 4 weeks and 8 weeks of follow-up as compared to changes detected by standard-of-care questionnaires HAMD-17 Changes in depression severity
To evaluate the ability of EmoDTx to predict changes in patient's mood earlier than the standard-of-care questionnaires MADRS, within 4 weeks and 8 weeks of follow-up.
Measured: Time to detection by EmoDTx of changes to depression severity symptoms within 4 weeks and 8 weeks of follow-up as compared to changes detected by standard-of-care questionnaires MADRS Changes in depression severity
Score EQ-5D-5L
Measured: At 4 weeks and 8 weeks
Change of EmoDTx score when feedback is deactivated
Measured: From baseline to 4 weeks
Change of EmoDTx score when feedback is activated
Measured: From 4 weeks to 8 weeks
Acceptability of medical device questionnaire
Measured: A baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start15 Jul 2025
- Primary completion9 Dec 2025 (estimated)
- Study completion9 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emobot
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nîmes University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860165
- Sponsor's protocol ID
- EMC2FR
- Other IDs
- 2024-A02120-47
- Acronym
- EMC2FR
- Status last verified
- Jul 2025
- First submitted
- 11 Feb 2025
- Last updated
- 22 Jul 2025
- 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 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients With Unipolar Depression: An Observational Study Against Standard Depression Assessment Questionnaires
- ClinicalTrials.gov ID
- NCT06860165
- Acronym / sponsor ID
- EMC2FR / EMC2FR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- EmobotIndustry (pharma, biotech, devices)
- Collaborators
- Nîmes University Hospital
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 9 Dec 2025 (estimated)
- Study completion
- 9 Dec 2025 (estimated)
- First posted
- 5 Mar 2025 (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 study is to validate the EmoDTx as a digital tool for mood monitoring in adult patients with unipolar depression. The study is prospective, multicenter, and observational, with a single-arm approach. The device studied, EmoDTx, is a mood-monitoring application that analyzes patients' facial expressions to assess their emotional state. The study aims to compare mood scores obtained via EmoDTx with those of standard depression questionnaires (MADRS, PHQ-9, BDI-II, HAMD-17, QIDS-SR16). It will also provide information on how patients feel about the use of passive monitoring software (without the active involvement of the patient) and how the feedback sent to patients can help in their care.
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 8-week follow-up period.
- Attend scheduled appointments at the center (a first appointment, then a second 4 weeks later, and a final at 8 weeks) to complete a series of questionnaires, be questioned by the doctor, and fill in other questionnaires on their own.
- At home, answer questionnaires independently, 2 weeks and 6 weeks after the first appointment.
- The application's feedback will be deactivated during the first 4 weeks and then reactivated during the final 4 weeks.
- In parallel, an ancillary study will be conducted on 16 patients enrolled in EMC2FR who accepted and performed the video recording of their structured clinical interview following SCID-5-CV at baseline and 4 weeks.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients suffering from mild to severe unipolar depression
Key inclusion criteria (5 listed)
- Outpatients diagnosed with mild to severe unipolar disorder
- Age ≥ 18 years old
- Patients willing and able to participate (i.e willing to use the EmoDTx App and having the necessary technical equipment to use it)
- Patients who read, write and understand French
- Patients having signed the Patient Informed Consent
Key exclusion criteria (17 listed)
- Patients hospitalized
- Patients taking more than 75% of the maximal recommended daily dose of benzodiazepines
- Patients taking more than 75% of the maximal recommended daily dose of antipsychotics
- Patients taking more than 75% of the maximal recommended daily dose of neuroleptics
- Patients who did not respond to 10 different pharmacological treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of score EmoDTx
Time frame: From baseline to 4 weeks
Absolute difference
Change of score MADRS administrated by an investigator
Time frame: From baseline to 4 weeks
Absolute difference
18 secondary outcomes
Change of EmoDTx score
Time frame: Between 2 weeks and 6 weeks
Change of score PHQ-9 self reported
Time frame: Between 2 weeks and 6 weeks
Change of EmoDTx score
Time frame: Between Baseline and 4 weeks, between Baseline and 8 weeks and between 4 weeks and 8 weeks
Change of HAMD-17 questionnaire administered by the investigator
Time frame: Between Baseline and 4 weeks, between Baseline and 8 weeks and between 4 weeks and 8 weeks
Change of EmoDTx score
Time frame: between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks
Change of score QIDS- SR16 self administrated
Time frame: between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks
Change of score BDI-II self administrated
Time frame: between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks
Score EmoDTx
Time frame: At 4-weeks, at 8 week
Score MADRS administrated by the investigator
Time frame: At 4-weeks, at 8 week
Score HAMD-17 administrated by the investigator
Time frame: At 4-weeks, at 8 week
Score PHQ-9 self administrated
Time frame: At 2-weeks and 6 weeks.
Score QIDS-SR16 self administrated
Time frame: At 4-weeks and 8 weeks
To evaluate the ability of EmoDTx to predict changes in patient's mood earlier than the standard-of-care questionnaires HAMD-17, within 4 weeks and 8 weeks of follow-up.
Time frame: Time to detection by EmoDTx of changes to depression severity symptoms within 4 weeks and 8 weeks of follow-up as compared to changes detected by standard-of-care questionnaires HAMD-17 Changes in depression severity
To evaluate the ability of EmoDTx to predict changes in patient's mood earlier than the standard-of-care questionnaires MADRS, within 4 weeks and 8 weeks of follow-up.
Time frame: Time to detection by EmoDTx of changes to depression severity symptoms within 4 weeks and 8 weeks of follow-up as compared to changes detected by standard-of-care questionnaires MADRS Changes in depression severity
Score EQ-5D-5L
Time frame: At 4 weeks and 8 weeks
Change of EmoDTx score when feedback is deactivated
Time frame: From baseline to 4 weeks
Change of EmoDTx score when feedback is activated
Time frame: From 4 weeks to 8 weeks
Acceptability of medical device questionnaire
Time frame: A baseline and 8 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 22 Jul 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unipolar Depression and Major Depressive Disorder (MDD), run by Emobot at 2 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 5 inclusion and 17 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 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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, contact@emobot.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of score EmoDTx (time frame: From baseline to 4 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 22 Jul 2025.