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

NCT07087353 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 594

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Mood Disorder (Depressive Episodes)

Interventions

DEVICE

Edra PRO

Remote monitoring software

Sponsors & Collaborators

  • Resilience

    lead INDUSTRY

Principal Investigators

  • Antoine Yrondi, MD, PhD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2027-04-01
Completion
2027-12-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07087353 on ClinicalTrials.gov