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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06123897
• Other study ID #: WU2023cohort
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2024
• Source: Central South University
• Contact: Renrong Wu, M.D., Ph.D.
• Phone: 15874179855
• Email: wurenrong2013[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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, 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.

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:

1. Establishing management specifications and systems for raw data. Emphasis is placed on protecting the authenticity, integrity, and traceability of raw data, and arbitrary changes are not allowed. In the process of data processing, if there are errors, omissions, or modifications needed, it should follow certain procedures and rules for revision (such as documenting all changes, including detailed information such as time, reasons, values before and after modification, and retaining the original erroneous data as a backup). Trace the entire data processing process to ensure that any changes have clear reasons and evidence support, avoiding the risk of tampering or false reporting.

2. Conduct regular consistency training. This project conducts consistency training for team members on scales and MCCB once every three months, including theoretical explanations, practical operation demonstrations, and practice discussions in various forms. This ensures that all scale assessors understand the design principles, applicability, assessment methods, and scoring criteria of the above scales, thereby reducing errors caused by improper operation.

3. Random inspections. This project also invites senior clinical physicians and researchers to conduct quality control of scale assessments and data collection processes through random inspections. This includes, but is not limited to, reviewing the operating procedures of participating researchers, data recording forms, equipment usage, and other aspects to ensure that all links are within a controllable range and comply with predetermined standards. If any problems or deviations are found, they should be corrected and relevant operating procedures adjusted in a timely manner to ensure continuous improvement in data quality, thereby reducing the error rate and the proportion of invalid data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2028
• Est. primary completion date: July 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Regular follow-up assessments without intervention.
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.
• Cross-sectional assessment
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.

Locations

Country	Name	City	State
China	Mental Health Institute of Second Xiangya Hospital,CSU	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Changes of the level of fasting blood glucose	Changes of fasting blood glucose	baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Secondary	Changes of the level of fasting insulin	Changes of fasting insulin	baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Secondary	Changes of the level of fasting glycated hemoglobin	Changes of fasting glycated hemoglobin	baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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