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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.
Full description
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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2,000 participants in 2 patient groups
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Central trial contact
Renrong Wu, M.D., Ph.D.; Hui Tang, M.D.
Data sourced from clinicaltrials.gov
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