Remote monitoring of depression and bipolar disorder: preliminary data on implementation from the EC-102 multicenter randomised controlled trial

Major depressive disorder (MDD) and bipolar disorder (BD) are chronic, relapsing conditions associated with significant functional impairment, elevated suicide risk, and substantial healthcare burden. Despite effective pharmacological treatments, remission rates remain suboptimal and the between-visit period represents a critical, largely unmonitored window during which early signs of deterioration or treatment non-adherence may go undetected. Remote patient monitoring (RPM) has emerged as a promising approach to address this gap, enabling continuous, real-time symptom tracking, early detection of clinical deterioration, and more timely therapeutic adjustment. By extending the reach of psychiatric care beyond the consultation room, RPM has the potential to improve treatment outcomes and reduce the risk of relapse and hospitalisation. Edra PRO is a CE-marked medical device specifically designed for the remote monitoring of patients with MDD or BD. It collects electronic patient-reported outcomes (ePROs) assessing symptom burden and treatment adherence, generates alerts based on predefined clinical thresholds, and provides clinicians with structured, longitudinal patient data between visits. Alerts are reviewed by case managers, who escalate to the psychiatrist when warranted. Despite growing interest in digital tools for psychiatric care, robust prospective clinical evidence supporting the integration of RPM into routine practice remains limited.

The EC-102 clinical trial aims to evaluate the clinical and organisational benefit of Edra PRO compared to usual care in improving treatment response in adult patients receiving pharmacological treatment for a major depressive episode, with or without BD, over a six-month period.

EC-102 (NCT07087353) is a multicentre prospective randomized controlled trial conducted across approximately 50 sites in France, including general hospitals, private practices, and clinics. A total of 594 adults with moderate-to-severe MDD or BD, newly initiated or adjusted on pharmacological treatment, are being enrolled and randomised to Edra PRO plus usual care or usual care alone. The trial follows a hybrid design with one in-person visit and remote follow-up via online questionnaires and Montgomery–Åsberg Depression Rating Scale (MADRS) at three and six months, performed by independent assessors. Patients in the intervention arm complete weekly Edra PRO questionnaires. The primary endpoint is the response rate at six months, defined as a reduction of ≥50% in the MADRS score from baseline. Secondary endpoints include remission and relapse rates, quality of life, healthcare utilisation, and treatment adherence.

Enrollment is ongoing across 50 French sites. Current demographic data show a predominantly female sample (69.7%) with a mean age of 40.2 years (standard deviation 14.1). With a median follow-up time of 2 months, interim feasibility outcomes are highly favourable: 99.4% of intervention-arm patients completed digital onboarding, and the overall weekly ePRO adherence rate to date is 84% (95% confidence interval: 77.0%–90.0%). Primary and secondary efficacy outcomes are expected in early 2027.

The EC-102 trial is actively enrolling across diverse clinical settings in France, demonstrating strong feasibility and real-world scalability of RPM in mood disorders. The high rates of onboarding completion and ePRO adherence support patient engagement with digital monitoring. EC-102 is the first Phase 3 RCT evaluating remote patient monitoring in MDD and BD, and definitive efficacy data will be available soon.

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