NCT06860165 Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients Suffering From Unipolar Depression
| NCT ID | NCT06860165 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emobot |
| Condition | Unipolar Depression |
| Study Type | OBSERVATIONAL |
| Enrollment | 98 participants |
| Start Date | 2025-07-15 |
| Primary Completion | 2025-12-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 98 participants in total. It began in 2025-07-15 with a primary completion date of 2025-12-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06860165 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Unipolar Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06860165 currently recruiting?
Yes, NCT06860165 is actively recruiting participants. Contact the research team at contact@emobot.fr for enrollment information.
Where is the NCT06860165 trial being conducted?
This trial is being conducted at Changé, France, Nîmes, France.
Who is sponsoring the NCT06860165 clinical trial?
NCT06860165 is sponsored by Emobot. The trial plans to enroll 98 participants.
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