www.radar-cns.org [email protected] 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 Background There is a growing body of literature highlighting the role that wearable and mobile remote measurement technology (RMT) can play in measuring major depressive disorder (MDD) symptoms. Predictors of depressive relapse include disrupted sleep, reduced sociability, physical activity, changes in mood, prosody and cognitive function, which are all amenable to measurement via RMT. This study forms part of the Innovative Medicines Initiative project: Remote Assessment of Disease and Relapse in the Central Nervous System (RADAR-CNS); a pan-European consortium, uniting experts in clinical research, engineering and computer science, aiming to improving managing MDD, epilepsy and multiple sclerosis. Aim The aims of RADAR-MDD are, in a sample of people with a history of MDD, to: 1) determine the usability, feasibility, and acceptability of RMT; 2) improve and refine clinical outcome measurement using RMT to identify current clinical state; 3) determine whether RMT can provide information predictive of depressive relapse and other critical outcomes. Design RADAR-MDD is a mullti-site prospective cohort study, aiming to recruit 600 participants with a history of depressive disorder across three sites: London, Amsterdam, and Barcelona. The primary outcome of interest is mDD relapse, defined via the Inventory of Depressive Symptomatology – Self-Report questionnaire (IDS-SR) and the World Health Organisation’s self- reported Composite International Diagnostic Interview (CIDI-SF). Secondary outcomes include: MDD remission; anxiety; self- esteem; quality of life; work disability; illness perceptions. We will additionally collect contextual information about changes in participants’ life circumstances which might affect outcomes: treatment for depression; adherence to medication; health service utilisation; stressful life events. AUTHORS: F Matcham 1 ([email protected]), C Barattieri 2,3 , V Bulgari 2,3 , G de Girolamo 2 , R Dobson 1 , H Eriksson 4 , A Folarin 1 , JM Haro 5 , M Kerz 1 , F Lamers 6 , DC Mohr 7 , I Myin-Germeys 8 , VA Narayan 9 , F Nobilia 1 , B Penninx 6 , M Ringkjøbing-Elema 4 , S Siddi 5 , S Simblett 1 , M Hotopf 1 , on behalf of the RADAR-CNS consortium 10 . 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