Dissecting Immunological and Autoimmune Mechanisms of Neuropsychiatric Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Neuronal Autoantibodies
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with Neuropsychiatric symptoms
- •Current or previous neuropsychiatric symptoms within the last year.
- •Suspicion of immunological contribution to the aetiology of their neuropsychiatric symptoms.
- •Control Participants
- •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.
排除标准
- •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.
结局指标
主要结局
Neuronal Autoantibodies
时间窗: 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.
次要结局
未报告次要终点