Efficacy of Remote Monitoring in Patients Treated for Moderate to Severe Major Depressive Episodes
EC-102
A Randomized Controlled Trial Assessing the Efficacy of Remote Patient Monitoring in Patients Treated for a Moderate to Severe Major Depressive Episode
2 other identifiers
interventional
594
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2025
CompletedFirst Posted
Study publicly available on registry
July 28, 2025
CompletedStudy Start
First participant enrolled
October 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
May 1, 2026
April 1, 2026
1.4 years
July 24, 2025
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Response rate over a 6-month period.
Difference in response rates (%) between the intervention group and the control group
Month 6
Secondary Outcomes (3)
Safety and absence of defects in Edra PRO over a 6-month period
Month 6
Impact of Edra PRO versus usual care on patients' quality of life
Month 6
Medico-economics impact of Edra PRO versus usual care
Month 6
Study Arms (2)
Intervention
EXPERIMENTALEdra PRO
Control
NO INTERVENTIONStandard care
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Resiliencelead
Study Sites (6)
CHU Besançon
Besançon, France
CHU Grenoble Alpes
Grenoble, France
EPSM de VEndée
La Roche-sur-Yon, France
CHU de Lille
Lille, France
Cabinet Corinne MARIE
Lisieux, France
CHU de Toulouse
Toulouse, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antoine Yrondi, MD, PhD
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2025
First Posted
July 28, 2025
Study Start
October 31, 2025
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share