Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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