Dissecting Immunological and Autoimmune Mechanisms of Neuropsychiatric Diseases (DIAMOND)

August 24, 2026 updated by: King's College London

The goal of this observational cohort study is to investigate the role of immune system in neuropsychiatric symptoms (NPS) and to identify immunological biomarkers that may improve the diagnosis, prognosis, and future treatment of immune-related neuropsychiatric disorders in individuals aged 16-100 years with suspected immune-mediated neuropsychiatric symptoms and matched control participants without neuropsychiatric symptoms.

The main questions it aims to answer are what immunological mechanisms are associated with neuropsychiatric symptoms across a range of neurological, psychiatric, autoimmune, infectious, and inflammatory conditions. Also, if immunological biomarkers can be identified that may support the diagnosis, prognosis, and future treatment of neuropsychiatric disorders in which the immune system may play a role.

Participants will provide a blood sample for immunological analysis and may optionally provide a cerebrospinal fluid (CSF) sample if a suitable previously collected sample is not available. Researchers may also analyse existing clinical and biological samples where available. Participants will provide demographic and clinical information, allow access to relevant medical record data, and may optionally provide additional blood samples, up to four times within one year, for further biomarker and immunological analyses.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, SE5 8AB
        • South London and Maudsley NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants with neuropsychiatric symptoms aged 16-100 will be recruited through participating clinical services, while control participants may be recruited through clinical services, research databases, social media, local research networks, and advertisements at collaborating universities and NHS sites.

Description

INCLUSION CRITERIA

Participants with Neuropsychiatric symptoms

  • Age 16-100.
  • Current or previous neuropsychiatric symptoms within the last year.
  • Suspicion of immunological contribution to the aetiology of their neuropsychiatric symptoms.

Control Participants

  • Age 16-100.
  • No current or previous self-report of neuropsychiatric symptoms within the last year.

Optional Lumbar Puncture only:

- Documented full blood count within the last 3 months with no clinically significant abnormalities.

EXCLUSION CRITERIA

All Participants:

  • Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance.
  • Inability to have blood tests.

Optional Lumbar Puncture only:

  • Significant lower spinal deformity (such as spina bifida), injury, or disease (such as stenosis) or previous lower spinal surgery.
  • Antiplatelet or anticoagulant therapy within the 14 days prior to Lumbar Puncture procedure.
  • Known or suspected clotting disorder.
  • Clinically significant abnormality in full blood count.
  • Known or suspected raised intracranial pressure, assessed by study clinician.
  • Known or suspected allergy to local anaesthetic agent or an ingredient of the anaesthetic solution.
  • History of chronic or recurrent headaches, in the opinion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control Participants
Participants with neuropsychiatric symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuronal Autoantibodies
Time Frame: From enrolment through to 1 year of follow-up.
Differences in the prevalence, subtype, and functional characteristics of neuronal autoantibodies in serum and cerebrospinal fluid between participants with neuropsychiatric symptoms (NPS) and matched control participants.
From enrolment through to 1 year of follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

King's College Hospital NHS Trust
South London and Maudsley NHS Foundation Trust
Francis Crick Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2036

Study Completion (Estimated)

October 1, 2036

Study Registration Dates

First Submitted

August 24, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 354922

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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