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| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| The Affiliated Brain Hospital of Nanjing Medical University | OTHER_GOV |
| Anhui Mental Health Center | UNKNOWN |
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This is a multicenter study conducted in collaboration with Central South University, The First Affiliated Hospital of Zhengzhou University, Nanjing Brain Hospital of Nanjing Medical University, and Anhui Mental Health Center. The project intends to employ standardized diagnostic criteria and clinical assessment procedures to establish a comprehensive cohort of patients with schizophrenia, encompassing all age groups and disease stages, with follow-up periods exceeding one year. The goal is to create an internationally high-standard clinical cohort database and biobank for schizophrenia. Through a multidimensional assessment framework, the project aims to further investigate the etiology of schizophrenia, patterns of disease progression, and clinical outcomes. By periodically capturing dynamic information on risk and preventive factors, the project aims to achieve early diagnosis, early treatment, and improved prognosis for patients. Additionally, it seeks to explore potential biomarkers within the realm of precision medicine that can predict treatment efficacy, providing viable tools for precision healthcare and clinical decision-making in the field of schizophrenia.
Participants screened through inclusion and exclusion criteria will be recruited and will undergo follow-up for a minimum of one year, with regular clinical data collection at baseline, half a month, 1st month, 3rd month, 6th month, 9th month, and 12th month.The information of demographic data, medical history and previous medication regimen will be collected at baseline. Current medication regimen, physical examination, anthropometry, electrocardiogram, electroencephalogram, psychiatry scales(Positive And Negative Syndrome Scale, Clinical Global Impression, Global Assessment Function and Personal and Social Performance Scale), the Measurement and Treatment Research to Improve Cognition in Schizophrenia(MATRICS) Consensus Cognitive Battery and blood test(blood routine, liver function, renal function, blood lipids, fasting blood glucose, fasting serum insulin, fasting blood glycosylated hemoglobin) will be performed at every follow-up timepoint, as well as functional MRI, eye movement and functional near-infrared spectroscope. If antipsychotic medication is already being used at baseline, the Simpson-Angus Scale (SAS), the Treatment Emergent Symptom Scale (TESS), and the Morisky Medication Adherence Scale (MMAS-8) are administered. Blood samples for exploring underlying mechanisms will be collected and stored at the same time for blood tests.
Data quality control is a crucial step in ensuring the quality and credibility of research data. This project has established a rigorous data quality control system to ensure the rigor and effectiveness of its research work:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with schizophrenia | Inclusion Criteria:
Exclusion criteria:
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| Healthy volunteers |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular follow-up assessments without intervention. | Other | Participants will undergo follow-up for a minimum of one year, with regular clinical data collection at baseline, half a month, 1st month, 3rd months, 6th months, 9th months and 12th months. Baseline assessments will include demographic information, medical history, and previous medication use. For participants on antipsychotics at baseline, the Simpson-Angus Scale for extrapyramidal symptoms(SAS) will also be administered. At baseline and each follow-up, data on current medication, physical examination, anthropometry, ECG, EEG, psychiatric scales (PANSS, CGI, GAF, PSP, SAS, TESS, MMAS-8), the MATRICS Consensus Cognitive Battery, and laboratory tests (blood routine, liver and renal function, lipids, fasting glucose, fasting insulin, HbA1c) will be obtained, alongside fMRI, eye movement, and fNIRS measures. Blood samples will be collected and stored for mechanistic investigations. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the MATRICS Consensus Cognitive Battery 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. The changes of scores at different follow up timepoint will be used for assessing the improvement of cognitive function (higher score means a better outcome). | baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month |
| Change of clinical symptoms by Positive And Negative Syndrome Scale | The change of Positive And Negative Syndrome Scale at different follow up timepoint (lower score means a better outcome) | baseline, half a month, 1st month, 3rd month, 6th month, 9thmonth, 12th 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) | baseline, half a month, 1st month, 3rd month, 6th month, 9thmonth, 12th month |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the level of blood lipids | Blood lipids include total cholesterol, low-density lipoprotein-cholesterol, triglyceride and high-density lipoprotein-cholesterol. | baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month |
| Change of Body Mass Index |
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Inclusion Criteria:
Exclusion criteria:
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Participants will be recruited from outpatient or inpatient departments.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renrong Wu, M.D., Ph.D. | Contact | 15874179855 | wurenrong2013@163.com | |
| Hui Tang, M.D. | Contact | 15802686545 | tanghuicsu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Renrong Wu, M.D., Ph.D. | Mental Health Institute of Second Xiangya Hospital,CSU | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Mental Health Center | Active, not recruiting | Hefei | Anhui | China | ||
| The First Affiliated Hospital of Zhengzhou University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41568002 | Derived | Yuan H, Wang MY, Liu RX, Sreekissoon S, Liu Q, Tan L, Zhao YQ, Zhong MM, Zhang Q, Su XL, Chen NX, Wang M, Yang YF, Li JN, Zheng HQ, Chen JD, Feng YZ, Zhang FY, Guo Y. Olanzapine affects bone formation via oral Enterococcus through SAA1 gene and extracellular matrix-related pathways. Front Cell Infect Microbiol. 2026 Jan 6;15:1673931. doi: 10.3389/fcimb.2025.1673931. eCollection 2025. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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serum, plasma
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| Cross-sectional assessment | Other | Volunteers will undergo assessments, including SCID scale, SCL-90, Chinese Perceived Stress Scale(CPSS), the Measurement and Treatment Research to Improve Cognition in Schizophrenia(MATRICS) Consensus Cognitive Battery, blood test(blood routine, liver function, renal function, blood lipids, fasting blood glucose, fasting serum insulin, fasting blood glycosylated hemoglobin), as well as functional MRI, eye movement, functional near-infrared spectroscope and electroencephalogram. Blood samples for exploring difference between patients and healthy people will be collected and stored. |
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BMI = weight/height^2,To some extent, Body Mass Index(BMI) can represent the situation of peripheral metabolism. |
| baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month |
| Change of waist-hip circumference | Change of waist-hip circumference,To some extent, waist-hip circumference can represent the situation of peripheral metabolism. | baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month |
| Changes of the level of fasting blood glucose | Changes of fasting blood glucose | baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month |
| Changes of the level of fasting insulin | Changes of fasting insulin | baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month |
| Changes of the level of fasting glycated hemoglobin | Changes of fasting glycated hemoglobin | baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month |
| Changes of functional MRI | Resting functional MRI will be acquired using a Fast Echo-Planar Imaging (FE-EPI) sequence based on Blood Oxygenation Level Dependent (BOLD) contrast. | baseline, 3rd month, 6th month, 9thmonth, 12th month |
| Changes of eye movement | Eye-tracking data will be collected using the EyeLink 1000 eye-tracking system from SR Research. The sampling frequency was 1000 Hz. Stimuli will be presented on a 24-inch computer monitor with a refresh rate of 120 Hz, and the viewing distance will be 70 centimeters. Eye movement data extraction and filtering will be performed using the Data Viewer 3.2 software, which is compatible with the EyeLink system. | baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month |
| Changes of brain hemodynamics detected by functional near-infrared spectroscope system | Changes of brain hemodynamics detected by functional near-infrared spectroscope system | baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month |
| Change of electroencephalogram | Neuroscan multi-channel evoked potential workstation records EEG data, using the international 10-20 system for electrode placement, with Ag/AgCl electrodes on a 64/128 electrode cap. | baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th 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. | baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month |
| Change of Global Assessment Function | Change of Global Assessment Function (GAF), higher score means a better outcome. | baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month |
| Active, not recruiting |
| Zhengzhou |
| Henan |
| 450052 |
| China |
| Mental Health Institute of Second Xiangya Hospital,CSU | Recruiting | Changsha | Hunan | 410011 | China |
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| Nanjing Brain Hospital, Nanjing Medical University | Active, not recruiting | Nanjing | Jiangsu | 210029 | China |