NCT06641726 | NOT YET RECRUITING | Bipolar Disorder (BD)

Detailed Description:

GlobalMinds is a research study with the goal of creating a precision psychiatry bioresource combining biological and clinical data on 50,000 participants with severe mental illness and dementia. The investigators will use this resource to investigate how genomics, other biological measures and non-biological risk factors are associated with these conditions and their outcomes. In addition, the investigators will deploy advanced analytic approaches to explore whether the combined dataset can help us derive more precise classification and diagnostic approaches and better prediction of outcomes. The investigators will also work with other researchers and enable access to the dataset to address these questions. In doing so, the investigators seek to enable the development of novel treatment options and improved, biologically informed classification for the most challenging conditions in psychiatry and dementia. The GlobalMinds programme is a precision neuroscience initiative (PNI). Its purpose is to improve the quality and availability of genomic and health care data for research into severe neuropsychiatric and degenerative ilnesses . The study will involve the whole genome sequencing from 50,000 patients suffering from neuropsychiatric and neurodegenerative disorders and linking this data to their individual electronic health records (EHRs) available within the Akrivia Health platform. No investigational product will be used, but the trial will deploy methods of clinical phenotyping, genomic sequencing, biobanking, diverse recruitment strategies in order to allow researchers to identify translatable biomarkers and disease-modifying targets for drug development downstream. This research study will develop a recruitment infrastructure that embraces the advantages conferred by the NHS research ecosystem, but crucially adds to existing NIHR and NHS strategies in order to meet our ambitious recruitment target. In GlobalMinds a national multi-media participant engagement campaign, delivered in partnership with the NHS, will direct patients with capacity to a centralised digital portal - the GlobalMinds Hub - to automate a large proportion of study activity. This process will be managed by a dedicated study team run by Akrivia Health. The GlobalMinds study team will monitor recruitment rates and sample diversity, provide quality assurance on participant-generated data, coordinate the network of expert project partners responsible for the national engagement campaign, PPI, and digital infrastructure, and crucially undertake local community outreach, targeted recruitment and in-person sample collection to minimise the risk of digital exclusion. For 40,000 participants who will provide DNA for whole genome sequencing, patients will be screened and recruited into the study remotely and issued a remote DNA capture pack that patients can use and return in their own time. Where participants express an interest in doing so, on-site and mobile phlebotomy services will be used to obtain bloods samples for participants electing to participate in the biomarker cohort. The investigators will use the Global Minds data resource to address broad research objectives, but also work with, and provide secure access to the data resource, for the wider research community, both academic and non-academic researchers in the UK and abroad. Levels of access will be determined by Akrivia's Data Access Committee upon request from a research team.