EmoDTx mood-monitoring app for adults with unipolar depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter, single-arm observational study will enroll adult outpatients with unipolar depression who install the EmoDTx application on a smartphone or computer and use it during an eight-week follow-up. EmoDTx passively analyzes facial expressions to generate mood scores that will be compared with standard clinician- and self-rated depression scales (MADRS, PHQ-9, BDI-II, HAMD-17, QIDS-SR16). Participants can activate or deactivate the software at any time and will attend scheduled visits for concurrent questionnaire assessments. The study will also collect patient feedback on passive monitoring and whether app-generated feedback helps in their care.

Why it matters

Who can join: the full rules

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

Where it's running

• Cabinet médical Sikorav - Chitic - Roux-Pertus
  Changé, France, France Recruiting
• Centre Hospitalier Universitaire de Nîmes
  Nîmes, France, France Recruiting

Study contacts

• Study coordinator: Tanel PETELOT
• Email: contact@emobot.fr
• Phone: +33 6 51 44 26 67

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.