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NCT Number: NCT06860165

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

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.

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Key information

Conditions

Unipolar Depression Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Major Depressive Disorder (MDD) Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cabinet médical Sikorav - Chitic - Roux-Pertus, Changé, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Primary outcomes

  1. Change of score EmoDTx

    Time frame: From baseline to 4 weeks

    Absolute difference

  2. Change of score MADRS administrated by an investigator

    Time frame: From baseline to 4 weeks

    Absolute difference

Secondary outcomes

  1. Change of EmoDTx score

    Time frame: Between 2 weeks and 6 weeks

  2. Change of score PHQ-9 self reported

    Time frame: Between 2 weeks and 6 weeks

  3. Change of EmoDTx score

    Time frame: Between Baseline and 4 weeks, between Baseline and 8 weeks and between 4 weeks and 8 weeks

  4. 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

  5. Change of EmoDTx score

    Time frame: between Baseline and 4 weeks - between Baseline and 8 weeks - between 4 weeks and 8 weeks

  6. 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

  7. 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

  8. Score EmoDTx

    Time frame: At 4-weeks, at 8 week

  9. Score MADRS administrated by the investigator

    Time frame: At 4-weeks, at 8 week

  10. Score HAMD-17 administrated by the investigator

    Time frame: At 4-weeks, at 8 week

  11. Score PHQ-9 self administrated

    Time frame: At 2-weeks and 6 weeks.

  12. Score QIDS-SR16 self administrated

    Time frame: At 4-weeks and 8 weeks

  13. 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

  14. 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

  15. Score EQ-5D-5L

    Time frame: At 4 weeks and 8 weeks

  16. Change of EmoDTx score when feedback is deactivated

    Time frame: From baseline to 4 weeks

  17. Change of EmoDTx score when feedback is activated

    Time frame: From 4 weeks to 8 weeks

  18. Acceptability of medical device questionnaire

    Time frame: A baseline and 8 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Tanel PETELOT

CONTACT

[email protected]

+33 6 51 44 26 67

Sponsors and collaborators

Lead sponsor

Emobot

Industry

Collaborators

  • Nîmes University Hospital

Registry information

Official study 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

Acronym: EMC2FR

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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