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Establishing a Clinical Database and Biobank for Schizophrenia:A Cohort Study
Sponsor: Central South University
Summary
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.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
2000
Start Date
2024-01-01
Completion Date
2028-12-31
Last Updated
2024-11-25
Healthy Volunteers
Yes
Conditions
Interventions
Regular follow-up assessments without intervention.
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.
Cross-sectional assessment
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.
Locations (4)
Anhui Mental Health Center
Hefei, Anhui, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Mental Health Institute of Second Xiangya Hospital,CSU
Changsha, Hunan, China
Nanjing Brain Hospital, Nanjing Medical University
Nanjing, Jiangsu, China