Remote monitoring with Edra PRO for people with moderate to severe depressive episodes

A Randomized Controlled Trial Assessing the Efficacy of Remote Patient Monitoring in Patients Treated for a Moderate to Severe Major Depressive Episode

This trial will try Edra PRO, a smartphone tool that remotely tracks symptoms, to see if it helps adults with moderate to severe major depressive episodes manage symptoms and care better than usual treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 594 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Resilience (Industry-sponsored)
• Locations: 6 sites (Besançon and 5 other locations)
• Trial ID: NCT07087353 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial compares Edra PRO, a digital medical device for remote symptom tracking and clinical decision support, with usual care in adults experiencing moderate to severe major depressive episodes. Participants use their personal smartphones to report symptoms and interact with the Edra PRO system while clinical teams receive remote monitoring data to guide care. Primary outcomes include symptom change, quality of life, healthcare use and costs, and secondary outcomes include comorbidities, adherence, and user satisfaction. The trial is conducted at several French hospital sites and enrolls patients who meet ICD-11 criteria and can use a smartphone independently.

Who should consider this trial

Good fit: Adults aged 18 or older with an ICD-11 diagnosis of a moderate to severe major depressive episode who have a personal smartphone, internet access, and are cognitively able to use the device independently are ideal candidates.

Not a fit: People who are pregnant, under legal guardianship, actively abusing alcohol or drugs in a way that interferes with participation, lacking smartphone/internet access, or with severe psychiatric or medical comorbidities likely to affect participation are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, Edra PRO could improve symptom monitoring and follow-up, leading to better symptom control, higher quality of life, and possibly lower healthcare costs for patients with moderate to severe depressive episodes.

How similar studies have performed: Similar digital remote-monitoring approaches in depression have shown mixed but promising results, often improving symptom tracking and engagement though large consistent symptom reductions have not been uniformly demonstrated.

Eligibility criteria

Inclusion Criteria:

* Adults (≥18 years old) meeting ICD-11 criteria for a moderate to severe major depressive episode
* Access to a personal smartphone and an internet connection, and cognitively able to use it independently

Exclusion Criteria:

* Pregnant women
* Individuals under legal guardianship or conservatorship
* Ongoing alcohol or drug abuse considered likely to interfere with study participation, as judged by the investigator
* Psychiatric or physical comorbidities (e.g., severe neurological or cardiovascular conditions) considered likely to interfere with participation or study results, at the discretion of the Principal Investigator

Where this trial is running

Besançon and 5 other locations

• CHU Besançon — Besançon, France (Recruiting)
• CHU Grenoble Alpes — Grenoble, France (Recruiting)
• EPSM de VEndée — La Roche-sur-Yon, France (Recruiting)
• CHU de Lille — Lille, France (Recruiting)
• Cabinet Corinne MARIE — Lisieux, France (Recruiting)
• CHU de Toulouse — Toulouse, France (Recruiting)

Study contacts

• Principal investigator: Antoine Yrondi, MD, PhD — University Hospital, Toulouse
• Study coordinator: Emma Touré Cuq, PharmD

Conditions Mood Disorder