Actively Recruiting

Age: 18Years +
All Genders
NCT06860165

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

Led by Emobot · Updated on 2025-07-22

98

Participants Needed

2

Research Sites

21 weeks

Total Duration

On this page

Sponsors

E

Emobot

Lead Sponsor

N

Nîmes University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Outpatients diagnosed with mild to severe unipolar disorder
  • Age 18 years or older
  • Willing and able to participate, including use of the EmoDTx App with necessary technical equipment
  • Able to read, write, and understand French
  • Signed the Patient Informed Consent
Not Eligible

You will not qualify if you...

  • Currently hospitalized
  • Taking more than 75% of the maximal recommended daily dose of benzodiazepines
  • Taking more than 75% of the maximal recommended daily dose of antipsychotics
  • Taking more than 75% of the maximal recommended daily dose of neuroleptics
  • Did not respond to 10 different pharmacological treatments
  • Attempted suicide within the last 6 months and has suicidal thoughts
  • Diagnosed with bipolar disorder
  • Contraindications to the device, including severe depression requiring hospitalization, schizophrenic disorders, major neurocognitive disorders, illiteracy, or institutionalization
  • Unable to read, write, and understand French
  • No access to a smartphone or computer with internet
  • Refuses to sign the Patient Informed Consent
  • Currently participating in another interventional clinical study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Cabinet médical Sikorav - Chitic - Roux-Pertus

Changé, France, France, 53810

Actively Recruiting

2

Centre Hospitalier Universitaire de Nîmes

Nîmes, France, France, 3090

Actively Recruiting

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Research Team

T

Tanel PETELOT

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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