ClinicalTrials.gov record NCT07791212

Dissecting Immunological and Autoimmune Mechanisms of Neuropsychiatric Diseases

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.

Age16 years old to 100 years old

SexAll

LocationUnited Kingdom

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational cohort study investigates the role of the immune system in people with neuropsychiatric symptoms and in matched control participants. Participants provide a blood sample and may optionally provide an existing or new cerebrospinal fluid (CSF) sample; researchers may also use existing clinical and biological samples and medical records. Participants may give additional blood samples (up to four times within one year) and will be followed for up to one year.

What it is studying. The study is testing which immunological mechanisms — including neuronal autoantibodies in blood and cerebrospinal fluid — are associated with neuropsychiatric symptoms, and whether immunological biomarkers can support diagnosis, prognosis, and future treatment of immune-related neuropsychiatric disorders.

What the researchers hope to learn. To describe immunological mechanisms linked to neuropsychiatric symptoms and to identify immunological biomarkers (for example, neuronal autoantibodies in serum and CSF) that may support future diagnosis, prognosis, and development of treatments.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

At enrollment participants provide a blood sample for immunological analysis. They may optionally give additional blood samples — up to four times within one year — and may optionally provide a cerebrospinal fluid (CSF) sample; providing CSF would require a lumbar puncture (spinal tap) if no suitable previously collected sample is available. Participants give demographic and clinical information and allow researchers to access relevant medical records. Researchers may also analyse any existing clinical or biological samples that are available; follow-up and sample collection may continue through one year after enrollment.

How the study is structured. A prospective observational cohort study comparing people with suspected immune-related neuropsychiatric symptoms to matched control participants without recent neuropsychiatric symptoms. Participants give demographic and clinical information, a blood sample for immunological analysis, and may optionally provide a CSF sample if no suitable previously collected sample exists. Additional blood samples (up to four) may be collected within one year, and researchers may access relevant medical records and existing clinical/biological samples. No treatments are assigned.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The registry says recruitment has not started. When is it expected to open, and can I register interest now?
The listed sites are in United Kingdom. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start: Oct 1, 2026 (estimated)
Primary completion: Oct 1, 2036 (estimated)
Study completion: Oct 1, 2036 (estimated)
Target enrollment: 300 participants (estimated)
Last updated on registry: Aug 27, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: King's College London
Collaborators: South London and Maudsley NHS Foundation Trust
Francis Crick Institute
King's College Hospital NHS Trust

Participating sites (2)

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

Terms used on this page · explanations by MedicalUpdates.ai

biomarkers: Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
Lumbar Puncture: A procedure in which a needle is placed between the bones of the lower back to collect spinal fluid or to give a treatment.
INCLUSION CRITERIA: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
EXCLUSION CRITERIA: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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