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