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

Not yet recruiting

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

• Registration Number: NCT06860165
• Lead Sponsor: Emobot

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study Start: 2025-03-03
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-12-09
• Study Completion: 2025-12-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of score EmoDTx	From baseline to 4 weeks	Absolute difference
Change of score MADRS administrated by an investigator	From baseline to 4 weeks	Absolute difference

Secondary Outcome Measures

Name	Time	Method
Change of EmoDTx score	between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks
Change of score PHQ-9 self reported	Between 2 weeks and 6 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 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