Immunoinflammatory State Detection and Multimodal Brain Imaging and Electrophysiologic Changes in Schizophrenia

Condition(s) studied

Investigational drug(s) / intervention(s)

Regular follow-up assessments without intervention.: Participants will receive a 3-month follow-up with clinical information, biological samples, and imaging data collected at baseline, 1st and 3rd months. The baseline assessment will include demographic information, medical history and previous medication use. At baseline and follow-up, patients' physical examination data (height, weight, waist and hip circumference, etc.), clinical symptom assessment scales (PANSS, SANS, SAPS, CDSS, CPSS, CGI, GAF, PSP, and SAS) and MCCB cognitive assessment data, blood and cerebrospinal fluid samples, MRI, and EEG data will be collected. Collection and store of blood and cerebrospinal fluid samples for routine laboratory tests and multi-omics including immunohistology, inflammation-related molecules, single-cell sequencing, extracellular vesicles, and other assays.

Cross-sectional assessment: Volunteers' physical examination data (height, weight, waist circumference, hip circumference, etc.), scale assessments (SCID, SCL-90, and CPSS) and MCCB cognitive assessment data, blood samples, MRI, and EEG data will be collected. Blood was collected and stored for exploring differences between patients and healthy individuals.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change of clinical symptoms by PANSS — baseline, 1st month, 3rd month
  The change of PANSS at different follow up timepoint (lower score means a better outcome).
• Change of the MCCB score — 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 MRI — 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 and central inflammatory factors — 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 — 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.
• Changes of peripheral immune cells — 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 — 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.

Trial sites (1)

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