Dissecting Immunological and Autoimmune Mechanisms of Neuropsychiatric Diseases

NCT07791212 | Not Yet Recruiting

• 1 other identifier: 354922
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Neuropsychiatric Symptom

Keywords

Neuropsychiatric Symptom; Neuroimmunology; Inflammation; Autoantibody; Autoimmune Encephalitis; Psychosis; LGI1; NMDAR; Catatonia; Lupus; Antipsychotic

Outcome Measures

Primary Outcomes (1)

• Neuronal Autoantibodies

  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.

Study Arms (2)

Participants with neuropsychiatric symptoms

Control Participants

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator
• Francis Crick Institute: collaborator
• King's College Hospital NHS Trust: collaborator

Study Sites (2)

South London and Maudsley NHS Foundation Trust

London, SE5 8AB, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and cerebrospinal fluid samples, occasional pathological specimens such as excised ovarian teratoma.

MeSH Terms

Conditions

Inflammation; Autoimmune Diseases of the Nervous System; Psychotic Disorders; Catatonia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2036
• Study Completion (Estimated): October 1, 2036
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

GB (2)