A Randomized Controlled Trial Assessing the Efficacy of Remote Patient Monitoring in Patients Treated for a Moderate to Major Depressive Episode
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Mood disorders like depression and bipolar disorder are widespread and cause serious psychological, cognitive, and social impairments, with a high burden on healthcare systems. Edra PRO is a digital medical device developed to support clinical decision-making and remotely monitor symptoms in psychiatric patients. The EC-102 randomized controlled trial will evaluate its impact compared to usual care on symptoms, quality of life, healthcare costs, comorbidities, and user adherence and satisfaction.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
CHU Besançon
RECRUITING
Besançon
CHU Grenoble Alpes
RECRUITING
Grenoble
EPSM de VEndée
RECRUITING
La Roche-sur-yon
CHU de Lille
RECRUITING
Lille
Cabinet Corinne MARIE
RECRUITING
Lisieux
CHU de Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Emma Touré Cuq, PharmD
emma.tourecuq@resilience.care
+33646396617
Backup
Charles Ferté
charles.ferte@resilience.care
Time Frame
Start Date: 2025-10-31
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 594
Treatments
Experimental: Intervention
Edra PRO
No_intervention: Control
Standard care
Related Therapeutic Areas
Sponsors
Leads: Resilience