A Randomized Controlled Trial Assessing the Efficacy of Remote Patient Monitoring in Patients Treated for a Moderate to Severe Major Depressive Episode
Sponsor: Resilience
Trial Details
| Condition | Mood Disorder (Depressive Episodes) |
| Intervention | Edra PRO |
| Phase | NA |
| Status | Recruiting |
| Participants | 594 |
| Est. Completion | 1 Apr 2027 |
| Last Updated | 1 May 2026 |
Primary Outcome
Response rate over a 6-month period.
Eligibility Criteria
Inclusion Criteria
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
Trial Sites
Countries
This content is for educational purposes for healthcare professionals only and does not constitute clinical advice. Clinical decisions should be based on individual patient assessment, current guidelines, and appropriate specialist consultation. Editorial Standards · Privacy Policy · Terms of Service