Impact of Remote Patient Monitoring On Major Depressive episode And Bipolar Disorder Treatment Outcomes: EC-102 Randomized Controlled Trial
A. Yrondi, A. Bourla, R. Belzeaux, E. Olié, R. David, J. Mallet, A. Amad, A. Sauvaget, M. Polosan, J. Holtzmann, F. Chevrier, E. Haffen, D. Bennabi, F. Stéphan, E. Artiges, A. Amrandi-Chickh, S. Bulteau, W. El-Hage, V. Rousseau, N. Lele, C. Martelli, L. Mekaoui, D. Jacon, G. Chabridon, L. Dormegny Jeanjean, F. Hermelin, E. Touré Cuq, P.-M. LlorcaIntroduction
Major depressive disorder (MDD) and bipolar disorder (BD) are chronic, disabling conditions marked by recurrent mood episodes that impair functioning and quality of life. Despite available treatments, remission rates are low, relapse is common, and symptom monitoring between visits remains limited. Remote patient monitoring (RPM) may help by enabling early detection and timely intervention. Edra PRO is a digital medical device indicated in the MDD and BD patient monitoring that collects electronic patient-reported outcomes (ePROs) and sends alerts to healthcare professionals to monitor symptoms remotely. While early data support its feasibility, robust clinical evidence is needed to demonstrate its impact and support wider adoption.
Objectives
The EC-102 trial aims to evaluate the clinical and organisational benefit of Edra PRO compared to usual care, in improving treatment response in adult patients undergoing pharmacological treatment for a moderate to severe major depressive episode, with or without BD, by comparing the impact of Edra PRO versus usual care on response rate, as measured by the MADRS score, over a 6-month period.
Methods
EC-102 is a multicentric, randomized, controlled, single-blind trial comparing Edra PRO to usual care over 6 months. Outcome assessors for the primary endpoint will be blinded to treatment allocation. An interim analysis is planned at 3 months. A total of 594 adult patients diagnosed with a moderate to severe MDD or BD, newly treated or adjusted on treatment, will be enrolled. At least 20% will have BD. Participants will be randomized 1:1 to receive either standard care and use the Edra PRO digital medical device (intervention) or standard care alone (control). The study follows a hybrid design, with one in-clinic visit and the rest conducted remotely through online questionnaires. Patients in the intervention group will complete weekly ePROs on mood symptoms, side effects, and treatment adherence via Edra PRO. Based on predefined clinical thresholds, the system automatically generates alerts that are sent to case managers for review and follow-up. Edra PRO aims to support timely clinical decisions without altering the underlying treatment plan. Usual care will remain unchanged in both groups. The primary endpoint is the difference in 6-month response rates (≥50% reduction in MADRS score from baseline). Secondary endpoints include 3 and 6-month response, remission and relapse rates, quality of life using EQ-5D-5L and SF-36, healthcare use, adherence to treatment, and safety.
Results
First results are expected for late 2026 and will be presented at the next EPA meeting.
Image 1: Long description.