Severe Mental Illness Longitudinal Evaluation (SMILE): protocol for establishing a cohort and bioresource for UK-based patients with psychosis.

INTRODUCTION: Psychotic disorders account for significant morbidity and healthcare costs and yet their pathophysiology remains poorly understood. The National Institute for Health and Care Research (NIHR) Severe Mental Illness Longitudinal Evaluation (SMILE) BioResource is a collaborative project that aims to collect clinical data and biological samples from people with psychosis for long-term storage, future projects and recontact for targeted trials. METHODS AND ANALYSIS: The NIHR SMILE BioResource cohort will initially include up to 2000 UK-based patients with a recorded diagnosis of psychosis. Clinical symptoms will be captured using self-report and clinician ratings. Biosamples will enable genotyping and wider omics as further funding allows. Study data will be analysed to facilitate development of discovery science for underlying mechanisms of psychotic disorders and recall of participants for targeted interventional studies. ETHICS AND DISSEMINATION: This study is sponsored by the University of Oxford and received full ethical approval from Wales REC 2. SMILE BioResource biosamples and data will be stored long-term by the NIHR BioResource. Researchers who are interested in applying to use these biosamples and data, and/or recontacting SMILE participants can find further information on the website of the NIHR BioResource.