Actively Recruiting
Efficacy of Remote Monitoring in Patients Treated for Moderate to Severe Major Depressive Episodes
Led by Resilience · Updated on 2026-05-01
594
Participants Needed
6
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Remote Monitoring in Patients Treated for Moderate to Severe Major Depressive Episodes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
CHU Besançon
Besançon, France
Actively Recruiting
2
CHU Grenoble Alpes
Grenoble, France
Actively Recruiting
3
EPSM de VEndée
La Roche-sur-Yon, France
Actively Recruiting
4
CHU de Lille
Lille, France
Actively Recruiting
5
Cabinet Corinne MARIE
Lisieux, France
Actively Recruiting
6
CHU de Toulouse
Toulouse, France
Actively Recruiting
Research Team
E
Emma Touré Cuq, PharmD
CONTACT
C
Charles Ferté
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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