RecruitingNot Applicable

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

France594 participantsStarted 2025-10-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Response rate over a 6-month period.

Timeframe: Month 6

Trial details

NCT IDNCT07087353

SponsorResilience

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-01

Contact for this trial

Emma Touré Cuq, PharmD

+33646396617 emma.tourecuq@resilience.care

View on ClinicalTrials.gov More Mood Disorder (Depressive Episodes) trials