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Clinical Trials in France / NCT07087353
Recruiting Not applicable

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

NCT07087353 · tracked via the Priya Life Science France tracker
Sponsor
Resilience
Phase
Not applicable
Started
2025-10-31
Last updated
2026-05-01

Condition(s) studied

Mood Disorder (Depressive Episodes)

Investigational drug(s) / intervention(s)

Edra PRO

Edra PRO: Remote monitoring software

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Response rate over a 6-month period. — Month 6
    Difference in response rates (%) between the intervention group and the control group

Trial sites (6)

FacilityCityRegionStatus
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

More Resilience trials in France

Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07087353 on ClinicalTrials.gov ↗ ← All trials in France