Clinical trial NCT06673966: Immunoinflammatory State Detection and Multimodal Brain Imaging and Electrophysiologic Changes in Schizophrenia
Official title: Immunoinflammatory State Detection and Multimodal Brain Imaging and Electrophysiologic Changes in Schizophrenia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Keywords: Schizophrenia
immunity
inflammation
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from outpatient or inpatient departments.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of clinical symptoms by PANSS
timeFrame: baseline, 1st month, 3rd month
measure: Change of the MCCB score
timeFrame: baseline, 1st month, 3rd month
measure: Changes of MRI
timeFrame: baseline, 1st month, 3rd month
measure: Changes of peripheral and central inflammatory factors
timeFrame: baseline, 1st month, 3rd month
measure: Changes of autoantibody
timeFrame: baseline, 1st month, 3rd month
measure: Changes of peripheral immune cells
timeFrame: baseline, 1st month, 3rd month
measure: EEG physiological detection index
timeFrame: baseline, 1st month, 3rd month
Secondary outcomes:
measure: Changes of other biological indicators
timeFrame: baseline, 1st month, 3rd month
measure: Change of clinical symptoms by Clinical Global Impression
timeFrame: baseline, 1st month, 3rd month
measure: Change of social function by Personal and Social Performance Scale
timeFrame: baseline, 1st month, 3rd month
measure: Change of Body Mass Index
timeFrame: baseline, 1st month, 3rd month
measure: Change of the level of blood lipids
timeFrame: baseline, 1st month, 3rd month
measure: Change of waist-hip circumference
timeFrame: baseline, 1st month, 3rd month
measure: Changes of the level of fasting blood glucose
timeFrame: baseline, 1st month, 3rd month
measure: Changes of Scale for Assessment of Positive Symptoms
timeFrame: baseline, 1st month, 3rd month
measure: Changes of Scale for Assessment of Negative Symptoms
timeFrame: baseline, 1st month, 3rd month
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of Psychiatry, the Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: