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

Last updated: April 22, 2025
Sponsor: Central South University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Schizotypal Personality Disorder (Spd)

Tourette's Syndrome

Autism

Treatment

Regular follow-up assessments without intervention.

Cross-sectional assessment

Clinical Study ID

NCT06673966
Immune inflammation
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  1. Clinical diagnosis or SCID-5-RV assessment confirming neurodevelopmental disorders,bipolar and related disorders, substance use disorders (excluding alcohol andtobacco).

  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, autoimmunedisease, etc.

  3. Presence of clearly defined genetic diseases, including tuberous sclerosis, multiplesclerosis, Kleefstra syndrome, 22q11.2 deletion syndrome, Prader-Willi syndrome,Klinefelter syndrome (47, XXY), etc.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Regular follow-up assessments without intervention.
Phase:
Study Start date:
January 10, 2025
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

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

    Changsha, Hunan 410011
    China

    Active - Recruiting

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