Clinical trial NCT06860165: Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients Suffering From Unipolar Depression
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Unipolar Depression
Major Depressive Disorder (MDD)
Depression
Lead sponsor: Emobot
Sponsor class: INDUSTRY
Collaborators: name: Nîmes University Hospital
First posted: 2025-03-05
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients suffering from mild to severe unipolar depression

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of score EmoDTx
timeFrame: From baseline to 4 weeks
measure: Change of score MADRS administrated by an investigator
timeFrame: From baseline to 4 weeks
Secondary outcomes:
measure: Change of EmoDTx score
timeFrame: Between 2 weeks and 6 weeks
measure: Change of score PHQ-9 self reported
timeFrame: Between 2 weeks and 6 weeks
measure: Change of EmoDTx score
timeFrame: Between Baseline and 4 weeks, between Baseline and 8 weeks and between 4 weeks and 8 weeks
measure: Change of HAMD-17 questionnaire administered by the investigator
timeFrame: Between Baseline and 4 weeks, between Baseline and 8 weeks and between 4 weeks and 8 weeks
measure: Change of EmoDTx score
timeFrame: between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks
measure: Change of score QIDS- SR16 self administrated
timeFrame: between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks
measure: Change of score BDI-II self administrated
timeFrame: between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks
measure: Score EmoDTx
timeFrame: At 4-weeks, at 8 week
measure: Score MADRS administrated by the investigator
timeFrame: At 4-weeks, at 8 week
measure: Score HAMD-17 administrated by the investigator
timeFrame: At 4-weeks, at 8 week
measure: Score PHQ-9 self administrated
timeFrame: At 2-weeks and 6 weeks.
measure: Score QIDS-SR16 self administrated
timeFrame: At 4-weeks and 8 weeks
measure: 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.
timeFrame: 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
measure: 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.
timeFrame: 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
measure: Score EQ-5D-5L
timeFrame: At 4 weeks and 8 weeks
measure: Change of EmoDTx score when feedback is deactivated
timeFrame: From baseline to 4 weeks
measure: Change of EmoDTx score when feedback is activated
timeFrame: From 4 weeks to 8 weeks
measure: Acceptability of medical device questionnaire
timeFrame: A baseline and 8 weeks
Other outcomes:
Locations:
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