Establishing a Clinical Database and Biobank for Schizophrenia：A Cohort Study
ConditionSchizophrenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCentral South University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
Participants will be recruited from outpatient or inpatient departments.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Regular follow-up assessments without intervention.
Other interventionParticipants 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.
Cross-sectional assessment
Other interventionVolunteers 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.
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Individuals with schizophrenia1 intervention
Group B: Healthy volunteers1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month2
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)
Time frame
baseline, half a month, 1st month, 3rd month, 6th month, 9thmonth, 12th month3
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)
Time frame
baseline, half a month, 1st month, 3rd month, 6th month, 9thmonth, 12th monthSecondary outcomes
1
Change of the level of blood lipids
Blood lipids include total cholesterol, low-density lipoprotein-cholesterol, triglyceride and high-density lipoprotein-cholesterol.
Time frame
baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month2
Change of Body Mass Index
BMI = weight/height\^2,To some extent, Body Mass Index(BMI) can represent the situation of peripheral metabolism.
Time frame
baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month3
Change of waist-hip circumference
Change of waist-hip circumference,To some extent, waist-hip circumference can represent the situation of peripheral metabolism.
Time frame
baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month4
Changes of the level of fasting blood glucose
Changes of fasting blood glucose
Time frame
baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Central South University
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborator
The Affiliated Brain Hospital of Nanjing Medical University
Collaborator
Anhui Mental Health Center
Collaborator
Source ClinicalTrials.gov