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Efficacy of Remote Monitoring in Patients Treated for Moderate to Major Depressive Episodes
Sponsor: Resilience
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.
Official title: A Randomized Controlled Trial Assessing the Efficacy of Remote Patient Monitoring in Patients Treated for a Moderate to Major Depressive Episode
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
594
Start Date
2025-10-31
Completion Date
2027-12-01
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
Edra PRO
Remote monitoring software
Locations (6)
CHU Besançon
Besançon, France
CHU Grenoble Alpes
Grenoble, France
EPSM de VEndée
La Roche-sur-Yon, France
CHU de Lille
Lille, France
Cabinet Corinne MARIE
Lisieux, France
CHU de Toulouse
Toulouse, France