RecruitingNCT06673966

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


Sponsor

Central South University

Enrollment

200 participants

Start Date

Jan 10, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This is an observational study examining the immune and brain changes in people with schizophrenia. Researchers are using blood tests, brain scans, and brain wave recordings (EEG) to better understand how inflammation in the body might relate to the symptoms and brain changes seen in schizophrenia. **You may be eligible if...** - You have a confirmed diagnosis of schizophrenia meeting international diagnostic criteria (ICD-11) - Your diagnosis has been verified using a structured clinical interview (SCID-5-RV) **You may NOT be eligible if...** - You have a neurodevelopmental disorder, bipolar disorder, or substance use disorder (other than tobacco or alcohol) - You have a serious acute physical illness such as brain injury, active heart disease, or autoimmune disease - You have a known genetic syndrome (such as 22q11.2 deletion syndrome or multiple sclerosis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERRegular 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.

OTHERCross-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.


Locations(1)

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

Changsha, Hunan, China

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NCT06673966


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