Immunoinflammatory State Detection and Multimodal Brain Imaging and Electrophysiologic Changes in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change of clinical symptoms by PANSS
研究概览
简要总结
Schizophrenia is a severe mental illness that seriously affects the health and functioning of patients. Previous studies have found immunoinflammatory abnormalities in the blood, cerebrospinal fluid, central nervous system, and neuroimaging of people with schizophrenia, along with therapeutic effects of anti-inflammatory drugs on schizophrenia. These evidences suggest a close relationship between schizophrenia and immunity and inflammation. Therefore, we consider that the state of immune inflammation is a potential subtype classification basis for schizophrenia, and hypothesize that immune classification based on peripheral-central multidimensional data is related to patient's response to medication and cognition.
详细描述
This is a single-center prospective cohort study with longitudinal follow-up of patients with schizophrenia and cross-sectional data from healthy controls matched for sex and age. Participants who meet the inclusion and exclusion criteria will receive a 3-month follow-up with clinical information, biological samples, and imaging data collected at baseline, 1st and 3rd months. The aim of this project is to analyze peripheral-central immune-inflammatory performance and changes in patients with different clinical subtypes of schizophrenia through the use of scale assessments, biospecimen analysis, and imaging data. The Positive and Negative Symptom Scale (PANSS) is used to evaluate the patient's clinical status; MATRICS Consensus Cognitive Battery (MCCB) is used to assess cognition; biological samples such as blood and cerebrospinal fluid are used for multi-omics including immunohistology, inflammation-related molecules, single-cell sequencing, and extracellular vesicles; multi-modal imaging scans are used to react to the brain's structure, function, water molecule diffusion properties, and magnetization; EEG is used to react to the electrophysiological situation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis that meets ICD-11 criteria for schizophrenia.
- •Confirmation of the diagnosis of schizophrenia using the SCID-5-RV.
排除标准
- •Clinical diagnosis or SCID-5-RV assessment confirming neurodevelopmental disorders, bipolar and related disorders, substance use disorders (excluding alcohol and tobacco).
- •Presence of severe or acute physical illnesses, including traumatic brain injury, intracranial space-occupying or infectious diseases, acute cardiovascular diseases, acute respiratory system diseases, acute hematological disorders, autoimmune disease, etc.
- •Presence of clearly defined genetic diseases, including tuberous sclerosis, multiple sclerosis, Kleefstra syndrome, 22q11.2 deletion syndrome, Prader-Willi syndrome, Klinefelter syndrome (47, XXY), etc.
结局指标
主要结局
Change of clinical symptoms by PANSS
时间窗: baseline, 1st month, 3rd month
The change of PANSS at different follow up timepoint (lower score means a better outcome).
Changes of MRI
时间窗: baseline, 1st month, 3rd month
Compare the intergroup differences and longitudinal changes in brain structure, function, DTI, and QSM between patients with schizophrenia and healthy volunteers, as well as patients with different clinical subtypes.
Changes of peripheral immune cells
时间窗: baseline, 1st month, 3rd month
Compare the intergroup differences and longitudinal changes of immune cells in the blood between patients with schizophrenia, healthy volunteers, and patients with different clinical subtypes.
EEG physiological detection index
时间窗: baseline, 1st month, 3rd month
Detect resting state and task state EEG, analyze and calculate each bandwidth of the EEG (e.g. Alpha, Beta, Theta, etc.) and the functional E/I ratio of EEG power spectrum.
Change of the MCCB score
时间窗: baseline, 1st month, 3rd month
After assessment at each visit, evaluator convert raw scores to scale scores, then to normalized T scores. T scores of seven domains and composite score are further calculated. Compare the intergroup differences and longitudinal changes of the MCCB score between patients with schizophrenia and healthy volunteers, as well as patients with different clinical subtypes.(higher scores mean a better outcome.)
Changes of peripheral and central inflammatory factors
时间窗: baseline, 1st month, 3rd month
Compare the levels and longitudinal changes of inflammatory factors in cerebrospinal fluid and blood between patients with schizophrenia and healthy volunteers, as well as patients with different clinical subtypes.
Changes of autoantibody
时间窗: baseline, 1st month, 3rd month
Compare the levels and longitudinal changes of autoantibody in cerebrospinal fluid and blood between patients with schizophrenia and healthy volunteers, as well as patients with different clinical subtypes.
次要结局
- Changes of other biological indicators(baseline, 1st month, 3rd month)
- Change of clinical symptoms by Clinical Global Impression(baseline, 1st month, 3rd month)
- Change of social function by Personal and Social Performance Scale(baseline, 1st month, 3rd month)
- Change of Body Mass Index(baseline, 1st month, 3rd month)
- Change of the level of blood lipids(baseline, 1st month, 3rd month)
- Change of waist-hip circumference(baseline, 1st month, 3rd month)
- Changes of the level of fasting blood glucose(baseline, 1st month, 3rd month)
- Changes of Scale for Assessment of Positive Symptoms(baseline, 1st month, 3rd month)
- Changes of Scale for Assessment of Negative Symptoms(baseline, 1st month, 3rd month)
研究者
Renrong Wu
professor
Central South University