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

Launched by EMOBOT · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new tool called EmoDTx, which is a mobile app designed to help monitor mood in adults dealing with unipolar depression, also known as major depressive disorder. The goal is to see how well EmoDTx can track emotional changes by analyzing facial expressions and comparing those results to traditional questionnaires that assess depression. The researchers want to understand how effective this digital tool is and how patients feel about using it in their daily lives.

To be eligible for the trial, participants need to be at least 18 years old, diagnosed with mild to severe unipolar depression, and able to read and understand French. They should also be comfortable using a smartphone or computer to access the EmoDTx app. If someone joins the study, they will install the app and use it for eight weeks while attending appointments to fill out questionnaires and discuss their mood with a doctor. The app will provide feedback on their emotional state, and they will have the option to turn it on or off as needed. Importantly, the trial is not yet recruiting, but it aims to offer new insights into how technology can support mental health care.

Gender

ALL

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