Establishing a Clinical Database and Biobank for Schizophrenia：A Cohort Study

Study Overview
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Brief Summary
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This 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.

Detailed Description
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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, 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. Blood samples for exploring underlying mechanisms will be collected and stored at the same time for blood tests.

Official Title
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Establishing a Clinical Database and Biobank for Schizophrenia：A Cohort Study

Conditions
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Schizophrenia

Intervention / Treatment
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* Other: Regular follow-up assessments without intervention.
* Other: Cross-sectional assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Clinical diagnosis of schizophrenia according to ICD-10. 2.Confirmation of the diagnosis of schizophrenia using the SCID-5-RV (DSM-5 Structured Clinical Interview for DSM-5 Disorders - Research Version). 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, 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals with schizophrenia<br> | Other: Regular follow-up assessments without intervention.<br>* Participants will undergo follow-up for a minimum of one year, with regular clinical data collection at baseline, 1st month, 3rd months, 6th months, 9th months and 12th months.<br>|
| Healthy volunteers<br>Inclusion Criteria: Ages 13-60 years old. Clinical diagnosis not meeting ICD-10 criteria for schizophrenia. Diagnosis not meeting schizophrenia criteria confirmed using SCID-5-RV (DSM-5 Structured Clinical Interview for DSM-5 Disorders - Research Version). Exclusion criteria are the same as for the schizophrenia patient group. | Other: Cross-sectional assessment<br>* Volunteers will undergo assessments, including SCID scale, SCL-90, 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, 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, 1st month, 3rd month, 6th month, 9thmonth, 12th month | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Cohort Study