Evaluating Remote Monitoring with Edra PRO for Adults Treated for Moderate to Severe Major Depressive Episodes

What this Trial Is About

Mood disorders such as depression and bipolar disorder affect many people worldwide and lead to serious psychological, cognitive, and social difficulties. These conditions place a heavy burden on healthcare systems. The trial evaluates Edra PRO, a digital medical device designed to support clinical decisions and remotely monitor symptoms in psychiatric patients. The study compares Edra PRO with usual care to assess effects on symptoms, quality of life, healthcare costs, comorbidities, and user satisfaction and adherence. Participants will be randomly assigned to either use Edra PRO, which offers remote monitoring through software, or receive standard care without this device. The study is designed as a randomized controlled trial with a single masking approach. The main study period lasts six months, during which the effects of the device on depression symptoms and other outcomes will be assessed. During the trial, participants will be monitored for response to treatment over six months. Researchers will also evaluate the safety and reliability of Edra PRO, its impact on quality of life, and economic effects compared to usual care. Participants must have access to a smartphone and internet and be able to use the device independently. The study aims to gather data on symptom changes, healthcare use, user satisfaction, and adherence over the study period.

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