An observational study in Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders and Mental Disorders, sponsored by Central South University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Central South University · Observational
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.
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 200 is above the median of 178 across 506 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →Central South University is the lead sponsor of 134 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited from outpatient or inpatient departments.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Regular follow-up assessments without intervention.
1. No diagnosis of any mental disorder. 2. First degree relatives without mental disorders. Exclusion criteria are the same as for the schizophrenia patient group.
Other: Cross-sectional assessment
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.
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.
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 month
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 month
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 month
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 month
Changes of autoantibody
Compare the levels and longitudinal changes of autoantibody 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 month
Changes of peripheral immune cells
Compare the intergroup differences and longitudinal changes of immune cells in the blood between patients with schizophrenia, healthy volunteers, and patients with different clinical subtypes.
Time frame: baseline, 1st month, 3rd month
EEG physiological detection index
Detect resting state and task state EEG, analyze and calculate each bandwidth of the EEG (e.g. Alpha, Beta, Theta, etc.) and the functional E/I ratio of EEG power spectrum.
Time frame: baseline, 1st month, 3rd month
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 month
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 month
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 month
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 month
Change of the level of blood lipids
Blood lipids include total cholesterol, low-density lipoprotein-cholesterol, triglyceride and high-density lipoprotein-cholesterol.
Time frame: baseline, 1st month, 3rd month
Change of waist-hip circumference
Change of waist-hip circumference,To some extent, waist-hip circumference can represent the situation of peripheral metabolism.
Time frame: baseline, 1st month, 3rd month
Changes of the level of fasting blood glucose
Changes of fasting blood glucose.
Time frame: baseline, 1st month, 3rd month
Changes of Scale for Assessment of Positive Symptoms
The change of Scale for Assessment of Positive Symptoms at different follow up timepoint (lower score means a better outcome).
Time frame: baseline, 1st month, 3rd month
Changes of Scale for Assessment of Negative Symptoms
The change of Scale for Assessment of Negative Symptoms at different follow up timepoint (lower score means a better outcome).
Time frame: baseline, 1st month, 3rd month
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.