RecruitingNCT06860165

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


Sponsor

Emobot

Enrollment

98 participants

Start Date

Jul 15, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is validating EmoDTx, a smartphone app designed to continuously monitor mood in people with unipolar depression, to see whether it can serve as a reliable digital measure (endpoint) in clinical trials and real-world treatment settings. **You may be eligible if...** - You are an adult (18+) being treated as an outpatient for mild to severe unipolar (non-bipolar) depression - You are willing and able to use the EmoDTx smartphone app - You read, write, and understand French **You may NOT be eligible if...** - You are currently hospitalized - You are taking high doses of benzodiazepines, antipsychotics, or neuroleptics (above 75% of the maximum recommended daily dose) - Your depression has not responded to 10 or more different medications - You attempted suicide within the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Cabinet médical Sikorav - Chitic - Roux-Pertus

Changé, France, France

Centre Hospitalier Universitaire de Nîmes

Nîmes, France, France

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NCT06860165


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