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

NCT06123897 | Recruiting

• 1 other identifier: WU2023cohort
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Schizophrenia

Keywords

Schizophrenia, Cohort Study

Outcome Measures

Primary Outcomes (3)

• 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

• 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, half a month, 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, half a month, 1st month, 3rd month, 6th month, 9thmonth, 12th month

Secondary Outcomes (12)

• Change of the level of blood lipids

  baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month

• Change of Body Mass Index

  baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month

• Change of waist-hip circumference

  baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month

• Changes of the level of fasting blood glucose

  baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month

• Changes of the level of fasting insulin

  baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month

Study Arms (2)

Individuals with schizophrenia

Inclusion Criteria: * 1.Clinical diagnosis of schizophrenia according to ICD-11. * 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.

Other: Regular follow-up assessments without intervention.

Healthy volunteers

* Inclusion Criteria: 1. Ages 13-60 years old. 2. Clinical diagnosis not meeting ICD-11 criteria for schizophrenia. 3. 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

Interventions

Regular follow-up assessments without intervention. OTHER

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.

Individuals with schizophrenia

Cross-sectional assessment OTHER

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.

Healthy volunteers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from outpatient or inpatient departments.

You may qualify if:

• Clinical diagnosis of schizophrenia according to ICD-11.
• Confirmation of the diagnosis of schizophrenia using the SCID-5-RV (DSM-5 Structured Clinical Interview for DSM-5 Disorders - Research Version).

You may not qualify if:

• Clinical diagnosis or SCID-5-RV assessment confirming neurodevelopmental disorders, bipolar and related disorders, substance use disorders (excluding alcohol and tobacco).
• 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.
• 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.

Sponsors & Collaborators

• Central South University: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Nanjing Brain Hospital, Nanjing Medical University: collaborator
• Anhui Mental Health Center: collaborator

Study Sites (4)

Anhui Mental Health Center

Hefei, Anhui, China

ACTIVE NOT RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

ACTIVE NOT RECRUITING

Mental Health Institute of Second Xiangya Hospital,CSU

Changsha, Hunan, 410011, China

RECRUITING

Nanjing Brain Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210029, China

ACTIVE NOT RECRUITING

Related Publications (1)

• Yuan H, Wang MY, Liu RX, Sreekissoon S, Liu Q, Tan L, Zhao YQ, Zhong MM, Zhang Q, Su XL, Chen NX, Wang M, Yang YF, Li JN, Zheng HQ, Chen JD, Feng YZ, Zhang FY, Guo Y. Olanzapine affects bone formation via oral Enterococcus through SAA1 gene and extracellular matrix-related pathways. Front Cell Infect Microbiol. 2026 Jan 6;15:1673931. doi: 10.3389/fcimb.2025.1673931. eCollection 2025.

  PMID: 41568002 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma

MeSH Terms

Conditions

Schizophrenia

Interventions

Methods

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Renrong Wu, M.D., Ph.D.

  Mental Health Institute of Second Xiangya Hospital,CSU

  STUDY CHAIR

Central Study Contacts

Renrong Wu, M.D., Ph.D.

CONTACT

15874179855; wurenrong2013@163.com

Hui Tang, M.D.

CONTACT

15802686545; tanghuicsu@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 9, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)