Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients Suffering From Unipolar Depression (EMC2FR)

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:

1. 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.
2. 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.
3. At home, answer questionnaires independently, 2 weeks and 6 weeks after the first appointment.
4. The application's feedback will be deactivated during the first 4 weeks and then reactivated during the final 4 weeks.
5. 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 Overview

• Status: Recruiting
• Conditions: Depression; Unipolar Depression; Major Depressive Disorder (MDD)

• Study Type: Observational
• Enrollment (Estimated): 98

Contacts and Locations

• Study Contact: Name: Tanel PETELOT; Phone Number: +33 6 51 44 26 67; Email: contact@emobot.fr

Study Locations

• France
  • Changé, France, 53810
    • Recruiting
    • Cabinet médical Sikorav - Chitic - Roux-Pertus
    • Contact: Clara Roux-Pertus; Phone Number: 02 43 53 32 80; Email: clara.roux.pertus@gmail.com
  • Nimes, France, 3090
    • Recruiting
    • Centre Hospitalier Universitaire de Nimes
    • Contact: Fabrice Boulet; Phone Number: 04 66 68 34 26; Email: fabrice.boulet@chu-nimes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients suffering from mild to severe unipolar depression

Description

Inclusion criteria:

1. Outpatients diagnosed with mild to severe unipolar disorder
2. Age ≥ 18 years old
3. Patients willing and able to participate (i.e willing to use the EmoDTx App and having the necessary technical equipment to use it)
4. Patients who read, write and understand French
5. Patients having signed the Patient Informed Consent

Exclusion criteria:

1. Patients hospitalized
2. Patients taking more than 75% of the maximal recommended daily dose of benzodiazepines
3. Patients taking more than 75% of the maximal recommended daily dose of antipsychotics
4. Patients taking more than 75% of the maximal recommended daily dose of neuroleptics
5. Patients who did not respond to 10 different pharmacological treatments
6. Patients who attempted suicide within the previous last 6 months and presenting with suicidal ideations
7. Patient presenting with bipolar disorders

8. 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
9. Patients unable to read, write and understand French
10. Patients with no access to a smartphone or a computer with an internet connection
11. Patients who refuse to sign the Patient Informed Consent
12. Patients already participating in another interventional clinical study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of score EmoDTx	Absolute difference	From baseline to 4 weeks
Change of score MADRS administrated by an investigator	Absolute difference	From baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change of EmoDTx score	Between 2 weeks and 6 weeks
Change of score PHQ-9 self reported	Between 2 weeks and 6 weeks
Change of EmoDTx score	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	Between Baseline and 4 weeks, between Baseline and 8 weeks and between 4 weeks and 8 weeks
Change of EmoDTx score	between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks
Change of score QIDS- SR16 self administrated	between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks
Change of score BDI-II self administrated	between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks
Score EmoDTx	At 4-weeks, at 8 week
Score MADRS administrated by the investigator	At 4-weeks, at 8 week
Score HAMD-17 administrated by the investigator	At 4-weeks, at 8 week
Score PHQ-9 self administrated	At 2-weeks and 6 weeks.
Score QIDS-SR16 self administrated	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 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 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	At 4 weeks and 8 weeks
Change of EmoDTx score when feedback is deactivated	From baseline to 4 weeks
Change of EmoDTx score when feedback is activated	From 4 weeks to 8 weeks
Acceptability of medical device questionnaire	A baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Emobot
• Collaborators: Nîmes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Estimated): December 9, 2025
• Study Completion (Estimated): December 9, 2025

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: EMC2FR; 2024-A02120-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No