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

Central South University

Status: Enrolling

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

Treatments: Other: Regular follow-up assessments without intervention.; Other: Cross-sectional assessment

Study type: Observational

Funder types: Other

Identifiers

NCT06673966

Immune inflammation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 16 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Individuals with schizophrenia

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.

Treatment:

Other: Regular follow-up assessments without intervention.

Healthy volunteers

Description:

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.

Treatment:

Other: Cross-sectional assessment