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

NCT06673966 | Recruiting

• 1 other identifier: Immune inflammation
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Keywords

Schizophrenia; immunity; inflammation

Outcome Measures

Primary Outcomes (7)

• 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

• 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 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

• 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 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

• 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

• 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

Secondary Outcomes (9)

• 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

Study Arms (2)

Individuals with schizophrenia

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.

Other: Regular follow-up assessments without intervention.

Healthy volunteers

1. No diagnosis of any mental disorder. 2. First degree relatives without mental disorders. Exclusion criteria are the same as for the schizophrenia patient group.

Other: Cross-sectional assessment

Interventions

Regular follow-up assessments without intervention. OTHER

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.

Individuals with schizophrenia

Cross-sectional assessment OTHER

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.

Healthy volunteers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from outpatient or inpatient departments.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Department of Psychiatry, the Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Inflammation

Interventions

Methods

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Renrong Wu, M.D., Ph.D.

CONTACT

+86 15874179855; wurenrong2013@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 5, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)