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

Not Applicable

Not yet recruiting

• Conditions: Mood Disorder (Depressive Episodes)

• Registration Number: NCT07087353
• Lead Sponsor: Resilience

Brief 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-25
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-30
• Study Start: 2025-10-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 594

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety and absence of defects in Edra PRO over a 6-month period	Month 6	Analysis of adverse events in both arms and reported device deficiencies in the intervention group
Impact of Edra PRO versus usual care on patients' quality of life	Month 6	Short Form-36 questionnaire. Ranges from 0 to 100, with higher scores indicating better health-related quality of life.