Dissecting Immunological and Autoimmune Mechanisms of Neuropsychiatric Diseases
ConditionNeuropsychiatric Symptom
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-100
SponsorKing's College London
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Age 16-100.
Current or previous neuropsychiatric symptoms within the last year.
Suspicion of immunological contribution to the aetiology of their neuropsychiatric symptoms.
Age 16-100.
Disqualifiers
Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance.
Inability to have blood tests.
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsGroup A: Participants with neuropsychiatric symptoms
Group B: Control Participants
Trial outcomes
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.
Time frame
From enrolment through to 1 year of follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College London
Lead sponsor
South London and Maudsley NHS Foundation Trust
Collaborator
Francis Crick Institute
Collaborator
King's College Hospital NHS Trust
Collaborator
Source ClinicalTrials.gov
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