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.
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
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
Parallel
Edra PRO
DeviceRemote monitoring software
Response rate over a 6-month period.
Difference in response rates (%) between the intervention group and the control group
Safety and absence of defects in Edra PRO over a 6-month period
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
Short Form-36 questionnaire. Ranges from 0 to 100, with higher scores indicating better health-related quality of life.
Medico-economics impact of Edra PRO versus usual care
Analysis of cost of care
