SchizophreniaSZIMNCT06673966
Immunoinflammatory State Detection and Multimodal Brain Imaging and Electrophysiologic Changes in Schizophrenia
An observational study of Schizophrenia and Schizophrenia Spectrum and Other Psychotic Disorders, run by Central South University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Mental Disorders
- What is being tested?
- Regular follow-up assessments without intervention. and Cross-sectional assessment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2025to 31 Dec 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will be recruited from outpatient or inpatient departments.
Who may be able to join
- Clinical diagnosis that meets ICD-11 criteria for schizophrenia.
- Confirmation of the diagnosis of schizophrenia using the SCID-5-RV.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Psychiatry, the Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Renrong Wu, M.D., Ph.D., +86 15874179855, wurenrong2013@163.com
About this study
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.
Read the 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.
- Being tested
- Regular follow-up assessments without intervention., Cross-sectional assessment
- Keywords
- Schizophrenia, immunity, inflammation
- Medical subject headings
- Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Mental Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular follow-up assessments without intervention.Other
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.
Cross-sectional assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with schizophrenia | 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. Receives: Other: Regular follow-up assessments without intervention. | |
| Healthy volunteers | 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. Receives: Other: Cross-sectional assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of clinical symptoms by PANSS
The change of PANSS at different follow up timepoint (lower score means a better outcome).
Measured: 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.)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 1st month, 3rd month
Secondary outcomes (9)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 1st month, 3rd month
Changes of the level of fasting blood glucose
Changes of fasting blood glucose.
Measured: 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).
Measured: 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).
Measured: baseline, 1st month, 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start10 Jan 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renrong Wu, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673966
- Sponsor's protocol ID
- Immune inflammation
- Acronym
- SZIM
- Status last verified
- Jul 2026
- First submitted
- 30 Oct 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoinflammatory State Detection and Multimodal Brain Imaging and Electrophysiologic Changes in Schizophrenia
- ClinicalTrials.gov ID
- NCT06673966
- Acronym / sponsor ID
- SZIM / Immune inflammation
- Keywords
- Schizophrenia, immunity, inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with schizophrenia | – | Other: Regular follow-up assessments without intervention.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. |
| Healthy volunteers | – | Other: Cross-sectional assessment1. No diagnosis of any mental disorder. 2. First degree relatives without mental disorders. Exclusion criteria are the same as for the schizophrenia patient group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be recruited from outpatient or inpatient departments.
Key inclusion criteria (2 listed)
- Clinical diagnosis that meets ICD-11 criteria for schizophrenia.
- Confirmation of the diagnosis of schizophrenia using the SCID-5-RV.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular 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. | Other | Individuals with schizophrenia |
| Cross-sectional assessmentVolunteers' 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. | Other | Healthy volunteers |
Primary outcome
Change of clinical symptoms by PANSS
Time frame: baseline, 1st month, 3rd month
The change of PANSS at different follow up timepoint (lower score means a better outcome).
Change of the MCCB score
Time frame: baseline, 1st month, 3rd month
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.)
Changes of MRI
Time frame: baseline, 1st month, 3rd month
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.
Changes of peripheral and central inflammatory factors
Time frame: baseline, 1st month, 3rd month
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.
Changes of autoantibody
Time frame: baseline, 1st month, 3rd month
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.
Changes of peripheral immune cells
Time frame: baseline, 1st month, 3rd month
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.
EEG physiological detection index
Time frame: baseline, 1st month, 3rd month
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.
9 secondary outcomes
Changes of other biological indicators
Time frame: baseline, 1st month, 3rd month
Change of clinical symptoms by Clinical Global Impression
Time frame: baseline, 1st month, 3rd month
Change of social function by Personal and Social Performance Scale
Time frame: baseline, 1st month, 3rd month
Change of Body Mass Index
Time frame: baseline, 1st month, 3rd month
Change of the level of blood lipids
Time frame: baseline, 1st month, 3rd month
Change of waist-hip circumference
Time frame: baseline, 1st month, 3rd month
Changes of the level of fasting blood glucose
Time frame: baseline, 1st month, 3rd month
Changes of Scale for Assessment of Positive Symptoms
Time frame: baseline, 1st month, 3rd month
Changes of Scale for Assessment of Negative Symptoms
Time frame: baseline, 1st month, 3rd month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizophrenia Spectrum and Other Psychotic Disorders, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renrong Wu, M.D., Ph.D. (+86 15874179855, wurenrong2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of clinical symptoms by PANSS (time frame: baseline, 1st month, 3rd month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.