Immunoinflammatory State Detection and Multimodal Brain Imaging and Electrophysiologic Changes in Schizophrenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCentral South University
About this trial
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
This trial accepts healthy volunteersQualifiers
Clinical diagnosis that meets ICD-11 criteria for schizophrenia.
Confirmation of the diagnosis of schizophrenia using the SCID-5-RV.
Disqualifiers
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.
Trial population
Participants will be recruited from outpatient or inpatient departments.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Regular follow-up assessments without intervention.
Other interventionParticipants 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.
Cross-sectional assessment
Other interventionVolunteers' 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Individuals with schizophrenia1 intervention
Group B: Healthy volunteers1 intervention
Trial outcomes
Primary outcomes
1
Change of clinical symptoms by PANSS
The change of PANSS at different follow up timepoint (lower score means a better outcome).
Time frame
baseline, 1st month, 3rd month2
Change of the MCCB score
After assessment at each visit, evaluator convert raw scores to scale scores, then to normalized T scores. T scores of seven domains and composite score are further calculated. Compare the intergroup differences and longitudinal changes of the MCCB score between patients with schizophrenia and healthy volunteers, as well as patients with different clinical subtypes.(higher scores mean a better outcome.)
Time frame
baseline, 1st month, 3rd month3
Changes of MRI
Compare the intergroup differences and longitudinal changes in brain structure, function, DTI, and QSM between patients with schizophrenia and healthy volunteers, as well as patients with different clinical subtypes.
Time frame
baseline, 1st month, 3rd month4
Changes of peripheral and central inflammatory factors
Compare the levels and longitudinal changes of inflammatory factors in cerebrospinal fluid and blood between patients with schizophrenia and healthy volunteers, as well as patients with different clinical subtypes.
Time frame
baseline, 1st month, 3rd monthSecondary outcomes
1
Changes of other biological indicators
Compare the levels and longitudinal changes of other biological indicators between patients with schizophrenia and healthy volunteers, as well as patients with different clinical subtypes.
Time frame
baseline, 1st month, 3rd month2
Change of clinical symptoms by Clinical Global Impression
The change of Clinical Global Impression at different follow up timepoint (lower score means a better outcome).
Time frame
baseline, 1st month, 3rd month3
Change of social function by Personal and Social Performance Scale
Change of social function by Personal and Social Performance Scale, higher score means a better outcome.
Time frame
baseline, 1st month, 3rd month4
Change of Body Mass Index
BMI = weight/height\^2,To some extent, Body Mass Index(BMI) can represent the situation of peripheral metabolism.
Time frame
baseline, 1st month, 3rd monthSponsors and contacts
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Source ClinicalTrials.gov