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 location...
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
Cabinet Corinne MARIE
RECRUITING
Lisieux
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

This content was sourced from clinicaltrials.gov

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