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RecruitingNCT06860165EMC2FRUpdated Jul 22, 2025

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

An observational study in Unipolar Depression, Major Depressive Disorder (MDD) and Depression, sponsored by Emobot. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-22.

Sponsored by Emobot · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jul 2025; still recruiting 1 year 2 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
98
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Unipolar Depression
  • Major Depressive Disorder (MDD)
  • Depression
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's planned enrollment of 98 is below the median of 150 across 653 observational studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Emobot is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients suffering from mild to severe unipolar depression

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

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
98 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Change of score EmoDTx

    Absolute difference

    Time frame: From baseline to 4 weeks

  2. Change of score MADRS administrated by an investigator

    Absolute difference

    Time frame: From baseline to 4 weeks

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

07

Study locations

2 of 2 sites recruiting
  • Cabinet médical Sikorav - Chitic - Roux-Pertus
    Changé, France 53810, France
    Recruiting
  • Centre Hospitalier Universitaire de Nîmes
    Nîmes, France 3090, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06860165
Lead sponsor
Emobot
Collaborators
Nîmes University Hospital
Responsible party
Sponsor
First posted
Mar 5, 2025
Start date
Jul 15, 2025
Primary completion
Dec 9, 2025 (estimated)
Completion
Dec 9, 2025 (estimated)
Last update
Jul 22, 2025

Study contacts

Tanel PETELOT
Contact
contact@emobot.fr
+33 6 51 44 26 67

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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