EmoDTx mood-monitoring app for adults with unipolar depression
Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients With Unipolar Depression: An Observational Study Against Standard Depression Assessment Questionnaires
This project will test whether the EmoDTx app, which analyzes facial expressions, can track mood in adults with unipolar depression and align with standard questionnaires.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emobot Industry-sponsored |
| Locations | 2 sites (Changé, France and 1 other locations) |
| Trial ID | NCT06860165 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter, single-arm observational study will enroll adult outpatients with unipolar depression who install the EmoDTx application on a smartphone or computer and use it during an eight-week follow-up. EmoDTx passively analyzes facial expressions to generate mood scores that will be compared with standard clinician- and self-rated depression scales (MADRS, PHQ-9, BDI-II, HAMD-17, QIDS-SR16). Participants can activate or deactivate the software at any time and will attend scheduled visits for concurrent questionnaire assessments. The study will also collect patient feedback on passive monitoring and whether app-generated feedback helps in their care.
Who should consider this trial
Good fit: Adults (≥18) with mild to severe unipolar depression who are outpatients, French-speaking, able and willing to use a smartphone or computer, and who consent to eight weeks of monitoring.
Not a fit: Patients who are hospitalized, have bipolar disorder, recent serious suicidal behavior, are on very high doses of benzodiazepines or antipsychotics, lack the necessary technology or French language fluency, or otherwise meet exclusion criteria are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, EmoDTx could provide continuous, low-burden mood tracking that helps clinicians detect changes sooner and personalize care.
How similar studies have performed: Previous digital phenotyping and facial-expression analysis studies have shown promising but mixed results, so this approach is partially supported but still requires validation against clinical scales.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Changé, France and 1 other locations
- Cabinet médical Sikorav - Chitic - Roux-Pertus — Changé, France, France (Recruiting)
- Centre Hospitalier Universitaire de Nîmes — Nîmes, France, France (Recruiting)
Study contacts
- Study coordinator: Tanel PETELOT
- Email: contact@emobot.fr
- Phone: +33 6 51 44 26 67
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.