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

Not yet recruiting

• Conditions: Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

• Registration Number: NCT06673966

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-11-02
• Study First Posted: 2024-11-05
• Study Start: 2024-12-01
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-06-01
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age, 16-50years.
2. Clinical diagnosis that meets ICD-11 criteria for schizophrenia.
3. Confirmation of the diagnosis of schizophrenia using the SCID-5-RV (DSM-5 Structured Clinical Interview for DSM-5 Disorders - Research Version).
4. Disease duration < 10 years.

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Exclusion Criteria

1. Clinical diagnosis or SCID-5-RV assessment confirming neurodevelopmental disorders, bipolar and related disorders, substance use disorders (excluding alcohol and tobacco).
2. 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.
3. 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).
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 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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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 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 other biological indicators	baseline, 1st month, 3rd month	Compare the levels and longitudinal changes of other biological indicators between patients with schizophrenia and healthy volunteers, as well as patients with different clinical subtypes.
Change of clinical symptoms by Clinical Global Impression	baseline, 1st month, 3rd month	The change of Clinical Global Impression at different follow up timepoint (lower score means a better outcome).
Change of social function by Personal and Social Performance Scale	baseline, 1st month, 3rd month	Change of social function by Personal and Social Performance Scale, higher score means a better outcome.
Change of Body Mass Index	baseline, 1st month, 3rd month	BMI = weight/height\^2,To some extent, Body Mass Index(BMI) can represent the situation of peripheral metabolism.
Change of the level of blood lipids	baseline, 1st month, 3rd month	Blood lipids include total cholesterol, low-density lipoprotein-cholesterol, triglyceride and high-density lipoprotein-cholesterol.
Change of waist-hip circumference	baseline, 1st month, 3rd month	Change of waist-hip circumference,To some extent, waist-hip circumference can represent the situation of peripheral metabolism.
Changes of the level of fasting blood glucose	baseline, 1st month, 3rd month	Changes of fasting blood glucose.
Changes of Scale for Assessment of Positive Symptoms	baseline, 1st month, 3rd month	The change of Scale for Assessment of Positive Symptoms at different follow up timepoint (lower score means a better outcome).
Changes of Scale for Assessment of Negative Symptoms	baseline, 1st month, 3rd month	The change of Scale for Assessment of Negative Symptoms at different follow up timepoint (lower score means a better outcome).