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

Inclusion Criteria2

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

Exclusion Criteria3

  • 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.

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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