NCT07087353

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

A Randomized Controlled Trial Assessing the Efficacy of Remote Patient Monitoring in Patients Treated for a Moderate to Major Depressive Episode

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 594 (estimated)
• Sponsor: Resilience · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Mood disorders such as depression and bipolar disorder affect a large portion of the global population and cause significant psychological, cognitive, and functional impairments, along with high healthcare costs. Despite available treatments, sustained remission is hard to achieve, and many patients experience persistent symptoms and treatment side effects. Continuous remote monitoring could improve care and outcomes. Edra PRO is a digital medical device designed for remote symptom tracking and clinical decision support in psychiatry. The EC-102 randomized controlled trial will assess the impact of Edra PRO versus usual care on symptoms, quality of life, healthcare costs, comorbidities, and user satisfaction and adherence.

Conditions

• Mood Disorder (Depressive Episodes)

Interventions

Type	Name	Description
DEVICE	Edra PRO	Remote monitoring software

Timeline

• Start date: 2025-10-31
• Primary completion: 2027-04-01
• Completion: 2027-12-01
• First posted: 2025-07-28
• Last updated: 2026-02-06

Locations

6 sites across 1 country: France