remote assessment of disease and relapse in major ... · radar-mdd is a mullti-site prospective...
TRANSCRIPT
This communication reflects the views of the RADAR-CNS consortium and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein.
This work has received support from the EU/EFPIA Innovative Medicines Initiative Joint Undertaking 2 (RADAR-CNS grant No 115902) www.imi.europa.eu
Remote Assessment of Disease and Relapse in Major Depressive Disorder (RADAR-MDD): Study Protocol
BackgroundThere is a growing body of literaturehighlighting the role that wearable and mobileremote measurement technology (RMT) canplay in measuring major depressive disorder(MDD) symptoms. Predictors of depressiverelapse include disrupted sleep, reducedsociability, physical activity, changes in mood,prosody and cognitive function, which are allamenable to measurement via RMT. This studyforms part of the Innovative MedicinesInitiative project: Remote Assessment ofDisease and Relapse in the Central NervousSystem (RADAR-CNS); a pan-Europeanconsortium, uniting experts in clinical research,engineering and computer science, aiming toimproving managing MDD, epilepsy andmultiple sclerosis.
AimThe aims of RADAR-MDD are, in a sample ofpeople with a history of MDD, to: 1) determinethe usability, feasibility, and acceptability ofRMT; 2) improve and refine clinical outcomemeasurement using RMT to identify currentclinical state; 3) determine whether RMT canprovide information predictive of depressiverelapse and other critical outcomes.
Design
RADAR-MDD is a mullti-siteprospective cohort study, aimingto recruit 600 participants with ahistory of depressive disorderacross three sites: London,Amsterdam, and Barcelona. Theprimary outcome of interest ismDD relapse, defined via theInventory of DepressiveSymptomatology – Self-Reportquestionnaire (IDS-SR) and theWorld Health Organisation’s self-reported CompositeInternational DiagnosticInterview (CIDI-SF).
Secondary outcomes include:MDD remission; anxiety; self-esteem; quality of life; workdisability; illness perceptions.
We will additionally collectcontextual information aboutchanges in participants’ lifecircumstances which might affectoutcomes: treatment fordepression; adherence tomedication; health serviceutilisation; stressful life events.
AUTHORS: F Matcham1 ([email protected]), C Barattieri2,3, V Bulgari2,3, G de Girolamo2, R Dobson1, H Eriksson4, A Folarin1, JM Haro5, M Kerz1, F Lamers6, DC Mohr7, I Myin-Germeys8, VA Narayan9, F Nobilia1, B Penninx6, M Ringkjøbing-Elema4, S Siddi5, S Simblett1, M Hotopf1, on behalf of the RADAR-CNS consortium10.
1. King’s College London, Institute of Psychiatry, Psychology and Neuroscience – London, UK | 2. Saint John of God Clinical Research Centre – Fatebenefratelli, Brescia, Italy | 3. Department of Psychology, Catholic Universit of the Sacred Heart – Milan, Italy | 4. H Lundbeck – Valby, Denmark | 5. Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, CIBERSAM, Universitat de Barcelona – Barcelona, Spain | 6. Department of Psychiatry and Amsterdam Public Health Research Institute, VU University Meidcal Centre -Amsterdam, The Netherlands | 7. Centre for Behavioral Intervention Technologies, Department of Preventive Medicine, Northwestern University – Chicago, IL, USA| 8. Department for Neurosciences, Center for Contextual Psychiatry, KU Leuven – Leuven, Belgium | 9. Janssen Research and Development, LLC – Titusville, NJ, USA | 10. https://www.radar-cns.org/
Figure 1 | The RADAR-CNS platform