NCT06641726

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
111mo left

Started May 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
May 2025Jul 2035

First Submitted

Initial submission to the registry

October 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

May 16, 2025

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2035

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2035

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

9.6 years

First QC Date

October 8, 2024

Last Update Submit

September 30, 2025

Conditions

Keywords

cross-sectionalobservationalbioresourcebiomarkerswhole genome sequencinglinked bioresourcedementianeuropsychiatric

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of participants with schizophrenia, bipolar disorder or schizoaffective disorder

    The primary outcome measure of this study is the diagnosis of participants with bipolar disorder, schizophrenia or schizoaffective disorder in accordance with ICD-10 criteria

    1 month from sample collection and baseline assessment.

Study Arms (3)

Cohort 1

40,000 participants with linked EHR and baseline assessments will provide a DNA sample only, via saliva or blood. This cohort will comprise even distribution across neuropsychiatric disorders including Schizophrenia, Major depressive disorder (MDD), and Bipolar diagnostic groups (approximately 13,300 patients in each group).

Other: Not applicable- observational study

Cohort 2

9,000 participants with linked EHR and baseline assessments patients will provide DNA, RNA, peripheral blood mononuclear cells (PBMCs), plasma and serum via blood. This cohort will also comprise even distribution across neuropsychiatric disorders including Schizophrenia, Major depressive disorder (MDD), and Bipolar diagnostic groups (approximately 3000 patients in each group).

Other: Not applicable- observational study

Cohort 3

1000 participants with Dementia who have linked EHR and assessments will provide DNA, RNA, peripheral blood mononuclear cells (PBMCs), plasma and serum via blood.

Other: Not applicable- observational study

Interventions

This is non-interventional, cross-sectional observational study and thus there is no intervention.

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants aged 18 and over with neuropsychiatric (MDD, BD or Schizophrenia) or Neurodegenerative disorder (dementia).

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GlobalMinds central study team

Oxford, Oxford, OX1 3HJ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Extracted DNA samples, plasma, serum and derived PBMCs

MeSH Terms

Conditions

Bipolar DisorderSchizophreniaDementia

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive Disorders

Study Officials

  • Prof. James Walters

    Cardiff University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
14 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 15, 2024

Study Start

May 16, 2025

Primary Completion (Estimated)

January 1, 2035

Study Completion (Estimated)

July 1, 2035

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Anonymised data will be shared with researchers at the discretion of the data access committee, but no individual identifiable patient data will be shared.

Locations