RecruitingNot Applicable

Creating a Global Research Database That Connects Genetic Information and Long-term Health Data to Improve Personalized Treatment for People With Serious Mental Illness

United Kingdom50,000 participantsStarted 2025-05-16

Plain-language summary

This observational study aims to provide new insights into the nature and classification of severe mental illness and dementias that in time should help improve diagnostic practise, and enable the development of new and improved treatments. The investigators will achieve aims by gathering information and biological samples from over 50,000 research participants and then linking this information with participants' electronic health records, genetic and other potential markers of mental illnesses (called biomarkers, derived from biological samples). The investigators will use this resource to analyse how potential risk factors - genetic, other biological and non-biological (related to the participants' life circumstances) - influence participants' experiences, symptoms, and outcomes (both mental and physical health). The investigators will also use advanced analysis to assess whether there may be better ways of grouping together and understanding the experiences of those with severe mental illnesses and dementias. Given the value and importance of this resource for advancing mental health research, the investigators will also make the data available to other researchers to pursue these broad research aims.

Who can participate

Age range

18 Years – 110 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- All participants must have an electronic health record in a primary or secondary care service. Mental Health cohort(s) • Have received a diagnosis and/or treatment/referral for mental illness for MDD, BD, Schizophrenia. • Having an available electronic health record • Current age 18+ (no upper age limit) • Can speak English Dementia cohort • Participants aged 18+ (no upper age limit) • Currently alive and are, or have been, old age psychiatry patients • Received relevant diagnosis or referral: EITHER • Clinical diagnosis of dementia, mild cognitive impairment (MCI) or subjective cognitive impairment (SCI) OR • Memory clinic referral • Must be willing and able to complete a validated cognitive assessment (MoCA or SLUMS). All dementia patients will undergo the extended biomarker analysis. Exclusion Criteria: \- Mental Health cohort(s) • Patients without capacity to provide consent. Dementia cohort • Inability to understand spoken and/or written spoken English • Individuals with intellectual disability. • Patients with dementia in Creutzfeldt-Jakob disease (CJD), Huntington's, HIV dementia, alcohol-related dementia, intellectual disability, traumatic brain injury at any time. • Patients diagnosed with depression (only an exclusion criterion for MCI/SCI patients), psychosis, bipolar disorder prior in the pre-index period - to be checked at screening.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnosis of participants with schizophrenia, bipolar disorder or schizoaffective disorder

Timeframe: 1 month from sample collection and baseline assessment.

Trial details

NCT IDNCT06641726

SponsorAkrivia Health

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2035-01-01

Contact for this trial

Samantha Yuille, PhD

(44) 7827018555 samantha.yuille@akriviahealth.com

View on ClinicalTrials.gov More Bipolar Disorder (BD) trials