Immunoinflammatory State Detection and Multimodal Brain Imaging and Electrophysiologic Changes in Schizophrenia (SZIM)

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Disorders; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders
• Intervention / Treatment: Other: Regular follow-up assessments without intervention.; Other: Cross-sectional assessment

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Renrong Wu, M.D., Ph.D.; Phone Number: +86 15874179855; Email: wurenrong2013@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • Recruiting
      • Department of Psychiatry, the Second Xiangya Hospital of Central South University
      • Contact: Renrong Wu, M.D., Ph.D.; Phone Number: +86 15874179855; Email: wurenrong2013@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from outpatient or inpatient departments.

Description

Inclusion Criteria:

1. Clinical diagnosis that meets ICD-11 criteria for schizophrenia.
2. Confirmation of the diagnosis of schizophrenia using the SCID-5-RV.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Individuals with schizophrenia; Inclusion Criteria: Clinical diagnosis that meets ICD-11 criteria for schizophrenia.; Confirmation of the diagnosis of schizophrenia using the SCID-5-RV. Exclusion criteria: 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.	Other: 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.
Healthy volunteers; No diagnosis of any mental disorder.; First degree relatives without mental disorders. Exclusion criteria are the same as for the schizophrenia patient group.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of clinical symptoms by PANSS	The change of PANSS at different follow up timepoint (lower score means a better outcome).	baseline, 1st month, 3rd month
Changes of peripheral and central inflammatory factors	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.	baseline, 1st month, 3rd month
Changes of peripheral immune cells	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.	baseline, 1st month, 3rd month
Changes of MRI	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.	baseline, 1st month, 3rd month
EEG physiological detection index	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.	baseline, 1st month, 3rd month
Change of the MCCB score	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.)	baseline, 1st month, 3rd month
Changes of autoantibody	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.	baseline, 1st month, 3rd month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Central South University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: November 2, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Schizophrenia; inflammation; immunity
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Schizophrenia; Mental Disorders; Inflammation; Schizophrenia Spectrum and Other Psychotic Disorders; Investigative Techniques; Methods
• Other Study ID Numbers: Immune inflammation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No