Clinical trial NCT06123897: Establishing a Clinical Database and Biobank for Schizophrenia：A Cohort Study
Official title: Establishing a Clinical Database and Biobank for Schizophrenia：A Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schizophrenia
Keywords: Schizophrenia, Cohort Study
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
name: Nanjing Brain Hospital, Nanjing Medical University
name: Anhui Mental Health Center
First posted: 2023-11-09
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from outpatient or inpatient departments.

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.

Detailed 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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of the MATRICS Consensus Cognitive Battery score
timeFrame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
measure: Change of clinical symptoms by Positive And Negative Syndrome Scale
timeFrame: baseline, half a month, 1st month, 3rd month, 6th month, 9thmonth, 12th month
measure: Change of clinical symptoms by Clinical Global Impression
timeFrame: baseline, half a month, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Secondary outcomes:
measure: Change of the level of blood lipids
timeFrame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
measure: Change of Body Mass Index
timeFrame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
measure: Change of waist-hip circumference
timeFrame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
measure: Changes of the level of fasting blood glucose
timeFrame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
measure: Changes of the level of fasting insulin
timeFrame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
measure: Changes of the level of fasting glycated hemoglobin
timeFrame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
measure: Changes of functional MRI
timeFrame: baseline, 3rd month, 6th month, 9thmonth, 12th month
measure: Changes of eye movement
timeFrame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
measure: Changes of brain hemodynamics detected by functional near-infrared spectroscope system
timeFrame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
measure: Change of electroencephalogram
timeFrame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
measure: Change of social function by Personal and Social Performance Scale
timeFrame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
measure: Change of Global Assessment Function
timeFrame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Mental Health Center
state: Anhui
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: Mental Health Institute of Second Xiangya Hospital,CSU
state: Hunan
city: Nanjing
country: China
facility: Nanjing Brain Hospital, Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Mental Health Institute of Second Xiangya Hospital,CSU
name: Renrong Wu, M.D., Ph.D.
role: STUDY_CHAIR
References: