Efficacy of Remote Monitoring in Patients Treated for Moderate to Severe Major Depressive Episodes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Edra PRO.
- Who it may be relevant to
- Registry conditions: Mood Disorder (Depressive Episodes). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Controlled Trial Assessing the Efficacy of Remote Patient Monitoring in Patients Treated for a Moderate to Severe Major Depressive Episode
Overview
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.
Detailed description
Mood disorders such as depression and bipolar disorder affect a large portion of the global population and cause significant psychological, cognitive, and functional impairments, along with high healthcare costs. Despite available treatments, sustained remission is hard to achieve, and many patients experience persistent symptoms and treatment side effects. Continuous remote monitoring could improve care and outcomes. Edra PRO is a digital medical device designed for remote symptom tracking and clinical decision support in psychiatry. The EC-102 randomized controlled trial will assess the impact of Edra PRO versus usual care on symptoms, quality of life, healthcare costs, comorbidities, and user satisfaction and adherence.
Interventions
- Device Edra PRO
Remote monitoring software
Primary outcome measures
- Response rate over a 6-month period. [Time frame: Month 6]
Secondary outcome measures (3)
- Safety and absence of defects in Edra PRO over a 6-month period [Time frame: Month 6]
- Impact of Edra PRO versus usual care on patients' quality of life [Time frame: Month 6]
- Medico-economics impact of Edra PRO versus usual care [Time frame: Month 6]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 6 centers
- CHU Besançon — Besançon
- CHU Grenoble Alpes — Grenoble
- EPSM de VEndée — La Roche-sur-Yon
- CHU de Lille — Lille
- Cabinet Corinne MARIE — Lisieux
- CHU de Toulouse — Toulouse
Identifiers
NCT: NCT07087353 · EC-102 · 2025-A01782-47