Efficacy of Remote Monitoring in Patients Treated for Moderate to Severe Major Depressive Episodes
A Randomized Controlled Trial Assessing the Efficacy of Remote Patient Monitoring in Patients Treated for a Moderate to Severe Major Depressive Episode
Resilience
594 participants
Oct 31, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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 Criteria4
- 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
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Interventions
Remote monitoring software
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT07087353