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

Overview

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.

Interventions

• 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 dat
• 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.

Primary outcome measures

• Change of clinical symptoms by PANSS [Time frame: baseline, 1st month, 3rd month]
• Change of the MCCB score [Time frame: baseline, 1st month, 3rd month]
• Changes of MRI [Time frame: baseline, 1st month, 3rd month]
• Changes of peripheral and central inflammatory factors [Time frame: baseline, 1st month, 3rd month]
• Changes of autoantibody [Time frame: baseline, 1st month, 3rd month]
• Changes of peripheral immune cells [Time frame: baseline, 1st month, 3rd month]
• EEG physiological detection index [Time frame: baseline, 1st month, 3rd month]

Secondary outcome measures (9)

• Changes of other biological indicators [Time frame: baseline, 1st month, 3rd month]
• Change of clinical symptoms by Clinical Global Impression [Time frame: baseline, 1st month, 3rd month]
• Change of social function by Personal and Social Performance Scale [Time frame: baseline, 1st month, 3rd month]
• Change of Body Mass Index [Time frame: baseline, 1st month, 3rd month]
• Change of the level of blood lipids [Time frame: baseline, 1st month, 3rd month]
• Change of waist-hip circumference [Time frame: baseline, 1st month, 3rd month]
• Changes of the level of fasting blood glucose [Time frame: baseline, 1st month, 3rd month]
• Changes of Scale for Assessment of Positive Symptoms [Time frame: baseline, 1st month, 3rd month]
• Changes of Scale for Assessment of Negative Symptoms [Time frame: baseline, 1st month, 3rd month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

China · 1 center

• Department of Psychiatry, the Second Xiangya Hospital of Central South University — Changsha

Identifiers

NCT: NCT06673966 · Immune inflammation

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗