Bipolar Disorder (BD)GlobalMindsNCT06641726
Creating a Global Research Database That Connects Genetic Information and Long-term Health Data to Improve Personalized Treatment for People With Serious Mental Illness
An observational study of Bipolar Disorder (BD) and Schizophrenia Disorders, run by Akrivia Health at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Bipolar Disorder (BD), Schizophrenia Disorders, Major Depressive Diorder
- What is being tested?
- Not applicable- observational study
- How many people
- 50,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 May 2025to 1 Jul 2035
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants aged 18 and over with neuropsychiatric (MDD, BD or Schizophrenia) or Neurodegenerative disorder (dementia).
Who may be able to join
- 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)
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Byron Tibbitts contact
United Kingdom1 site, 1 recruiting
- Recruiting
GlobalMinds central study team
Oxford, Oxford, OX1 3HJ
Samantha Yuille, +44 (0)330 332 4878., samantha.yuille@akriviahealth.com
About this study
Official title: Developing an Internationally-diverse, Linked Genomic and Longitudinal Phenotypic Research Dataset to Accelerate Precision Psychiatry for Patients With Serious Mental Illness
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.
Read the 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.
- Being tested
- Not applicable- observational study
- Keywords
- cross-sectional, observational, bioresource, biomarkers, whole genome sequencing, linked bioresource, dementia, neuropsychiatric
- Medical subject headings
- Bipolar Disorder, Schizophrenia, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
This is non-interventional, cross-sectional observational study and thus there is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month from sample collection and baseline assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start16 May 2025
- Primary completion1 Jan 2035 (estimated)
- Study completion1 Jul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder (BD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Akrivia Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cardiff University
- Responsible party
- Sponsor
- Investigators
- Prof. James Walters, Principal investigator, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641726
- Sponsor's protocol ID
- GM001
- Other IDs
- 328854
- Acronym
- GlobalMinds
- Status last verified
- Sep 2025
- First submitted
- 8 Oct 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised data will be shared with researchers at the discretion of the data access committee, but no individual identifiable patient data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Internationally-diverse, Linked Genomic and Longitudinal Phenotypic Research Dataset to Accelerate Precision Psychiatry for Patients With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT06641726
- Acronym / sponsor ID
- GlobalMinds / GM001
- Keywords
- cross-sectional, observational, bioresource, biomarkers, whole genome sequencing, linked bioresource, dementia, neuropsychiatric
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Akrivia HealthIndustry (pharma, biotech, devices)
- Collaborators
- Cardiff University
- Study start
- 16 May 2025 (actual)
- Primary completion
- 1 Jan 2035 (estimated)
- Study completion
- 1 Jul 2035 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 14 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Not applicable- observational study40,000 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). |
| Cohort 2 | – | Other: Not applicable- observational study9,000 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). |
| Cohort 3 | – | Other: Not applicable- observational study1000 participants with Dementia who have linked EHR and assessments will provide DNA, RNA, peripheral blood mononuclear cells (PBMCs), plasma and serum via blood. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants aged 18 and over with neuropsychiatric (MDD, BD or Schizophrenia) or Neurodegenerative disorder (dementia).
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyThis is non-interventional, cross-sectional observational study and thus there is no intervention. | Other | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Diagnosis of participants with schizophrenia, bipolar disorder or schizoaffective disorder
Time frame: 1 month from sample collection and baseline assessment.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No. Anonymised data will be shared with researchers at the discretion of the data access committee, but no individual identifiable patient data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Byron Tibbitts contact
Prof. James Walters principal investigator
Cardiff University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder (BD) and Schizophrenia Disorders, run by Akrivia Health at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Yuille, PhD ((44) 7827018555, samantha.yuille@akriviahealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of participants with schizophrenia, bipolar disorder or schizoaffective disorder (time frame: 1 month from sample collection and baseline assessment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.