Clinical Trial

Efficacy of Remote Monitoring in Patients Treated for Moderate to Severe Major Depressive Episodes

Study acronym: EC-102
Recruiting
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-07-24; most recent amendment 2026-04-27.
Status change: Not Yet Recruiting → Recruiting 2025-12-08
Trial Details
NCT Number NCT07087353
Lead Sponsor Resilience
Conditions Mood Disorder (Depressive Episodes)
Enrollment 594 participants
Start Date 2025-10-31
Primary Completion 2027-04-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-01