EPP223
Impact of Remote Patient Monitoring On Major Depressive episode And Bipolar Disorder Treatment Outcomes: EC-102 Randomized Controlled Trial
A. Yrondi 1, A. Bourla 2 3 4 5, R. Belzeaux 6 7, E. Olié 8 9 10, R. DAVID 11 12, J. Mallet 13 14 15, A. Amad 16, A. Sauvaget 17,*, M. Polosan 18 19, J. Holtzmann 20, F. Chevrier 21, E. Haffen 22 23, D. Bennabi 22 23, F. Stéphan 24, E. Artiges 25, A. Amrandi-Chickh 25, S. Bulteau 26 27, W. El-Hage 28 29, V. Rousseau 30, N. Lele 31, C. Martelli 32, L. Mekaoui 33, D. Jacon 34, G. Chabridon 35, L. Dormegny Jeanjean 36 37, F. Hermelin 38, E. Touré Cuq 39, P.-M. Llorca 40 41
1Service de Psychiatrie et de Psychologie Médicale de l’adulte, Centre Expert Dépression Résistante FondaMental, CHU de Toulouse, Hôpital Purpan, ToNIC Toulouse NeuroImaging Centre, Université de Toulouse, INSERM, UPS, Toulouse, 2Department of Psychiatry, , Saint-Antoine Hospital, Sorbonne University, 3Assistance publique Hôpitaux de Pari, 4Medical Strategy and Innovation Department, Clariane, 5 NeuroStim Psychiatry Practice, Paris, 6IGF, Univ. Montpellier, CNRS, INSERM, 7Service de psychiatrie, 8Service de Psychiatrie d'Urgence et de Soins Aigus, CHU Montpellier, 9Université Montpellier, 10 IGF, CNRS, INSERM,, Montpellier, 11 CHU de Nice , 12Université Côte d'Azur, Nice, 13Service de psychiatrie adulte, Hôpital Louis Mourier, AP-HP, Paris, 14Service de psychiatrie adulte, EPSM du Loiret, Centre Hospitalier Universitaire d'Orléans , 15B-CLINE, Laboratoire Interdisciplinaire pour l'Innovation et la Recherche en Santé d'Orléans (LI²RSO), Université d'Orléans, Orléans, 16U1172 - LilNCog - Lille Neuroscience & Cognition, F-59000, CHU Lille, Lille, 17EPSM de Vendée, Centre Hospitalier Georges Mazurelle, La-Roche-sur-Yon, 18Inserm U1216, Univ. Grenoble Alpes , 19Grenoble Institut de Neurosciences, CHU de Grenoble, 20 Service de Psychiatrie Adulte, CHU Grenoble Alpes, Grenoble, 21unité de réhabilitation psychosociale, Clinique château Caradoc,, Bayonne, 22Service de Psychiatrie Clinique , CHU de Besançon, 23CIC-1431 INSERM, Université de Franche-Comté UMR 1322 LINC, Besançon, 24Service Hospitalo-Universitaire de Psychiatrie Générale et de Réhabilitation Psycho-Sociale 29G01/29G02, CHRU de Brest, Brest, 25LaB-D Psy, EPS Barthélémy Durand, Etampes, 26Pôle Hospitalo-Universitaire de Psychiatrie, CHU de Nantes, 27Inserm U1246 SPHERE, Nantes Université, Nantes, 28Service de Psychiatrie, CHRU de Tours, 29Inserm U1253, Université de Tours, Tours, 30Centre hospitalier la chartreuse, Dijon, 31Clinique d’Yveline, Vieille-Église-en-Yvelines, 32Département de Psychiatrie et Addictologie, AP-HP Hôpital Paul-Brousse, Villejuif, 33GHU Paris Psychiatrie & Neurosciences, CMME, Hôpital Sainte-Anne, Paris, 34Cabinet de Psychiatrie, Biarritz, 35Service de psychiatrie adulte, CHU Dijon-Bourgogne, Dijon, 36Centre de Neuromodulation Non-invasive de Strasbourg (CEMNIS), Service de Physiologie et d'Explorations Fonctionnelles, Hôpitaux Universitaires de Strasbourg, 37UMR CNRS 7357 ICube, Université de Strasbourg, Strasbourg, 38Service de psychiatrie , CHU d'Orléans, Hopital de la source, Orléans, 39Medical department, Resilience , Biarritz, 40Service de Psychiatrie, CHU de Clermont-Ferrand, 41Université Clermont-Ferrand, Clermont-Ferrand, France
Introduction: 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.
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Conclusions: The results will provide valuable insights into the clinical benefit of the RPM device Edra, particularly its impact on symptom improvement, patient adherence, care pathways, and overall quality of life in individuals with MDD.
Disclosure of Interest: A. Yrondi: None Declared, A. Bourla: None Declared, R. Belzeaux: None Declared, E. Olié: None Declared, R. DAVID: None Declared, J. Mallet: None Declared, A. Amad: None Declared, A. Sauvaget: None Declared, M. Polosan: None Declared, J. Holtzmann: None Declared, F. Chevrier: None Declared, E. Haffen: None Declared, D. Bennabi: None Declared, F. Stéphan: None Declared, E. Artiges : None Declared, A. Amrandi-Chickh: None Declared, S. Bulteau : None Declared, W. El-Hage Consultant of: Air Liquide, Boehringer-Ingelheim, Chugai, Eisai, Janssen Cilag, Jazz Pharmaceuticals, Lundbeck, Mapreg SAS, Mindforce Game Lab, Novartis, Otsuka, UCB., V. Rousseau: None Declared, N. Lele : None Declared, C. Martelli: None Declared, L. Mekaoui: None Declared, D. Jacon : None Declared, G. Chabridon : None Declared, L. Dormegny Jeanjean: None Declared, F. Hermelin: None Declared, E. Touré Cuq: None Declared, P.-M. Llorca Consultant of: Ethypharm et Semeia