RecruitingNCT06123897

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

Sponsor

Central South University

Enrollment

2,000 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

Schizophrenia

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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study is building a long-term clinical database and biological sample bank (biobank) for people with schizophrenia. The purpose is to collect detailed clinical information and biological samples (such as blood) over time to better understand how schizophrenia develops and to support future research into treatments. **You may be eligible if...** - You have been diagnosed with schizophrenia based on ICD-11 criteria - Your diagnosis has been confirmed using a structured clinical interview (SCID-5-RV) **You may NOT be eligible if...** - You have been diagnosed with a neurodevelopmental disorder, bipolar disorder, or a substance use disorder (other than alcohol or tobacco) - You have a severe or acute physical illness such as traumatic brain injury, brain infection, acute heart or lung disease, or a blood disorder - You have a clearly identified genetic syndrome (such as 22q11.2 deletion syndrome or Klinefelter syndrome) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERRegular 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.

OTHERCross-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.