SchizophreniaNCT06123897
Establishing a Clinical Database and Biobank for Schizophrenia：A Cohort Study
An observational study of Schizophrenia, run by Central South University at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Regular follow-up assessments without intervention. and Cross-sectional assessment
- How many people
- 2,000 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jan 2024to 31 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will be recruited from outpatient or inpatient departments.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 1 recruiting
- Recruiting
Mental Health Institute of Second Xiangya Hospital,CSU
Changsha, Hunan, 410011
Renrong Wu, PhD, M.D, 15874179855, wurenrong2013@163.com
Hui Tang, M.D, 15802686545, tanghuicsu@163.com
- Active, not recruiting
Anhui Mental Health Center
Hefei, Anhui
- Active, not recruiting
Nanjing Brain Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210029
- Active, not recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
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.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- Schizophrenia
- Being tested
- Regular follow-up assessments without intervention., Cross-sectional assessment
- Keywords
- Schizophrenia, Cohort Study
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Cross-sectional assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Cross-sectional assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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)
Measured: baseline, half a month, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Secondary outcomes (12)
Change of the level of blood lipids
Blood lipids include total cholesterol, low-density lipoprotein-cholesterol, triglyceride and high-density lipoprotein-cholesterol.
Measured: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Change of Body Mass Index
BMI = weight/height^2,To some extent, Body Mass Index(BMI) can represent the situation of peripheral metabolism.
Measured: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Change of waist-hip circumference
Change of waist-hip circumference,To some extent, waist-hip circumference can represent the situation of peripheral metabolism.
Measured: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Changes of the level of fasting blood glucose
Changes of fasting blood glucose
Measured: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Changes of the level of fasting insulin
Changes of fasting insulin
Measured: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Changes of the level of fasting glycated hemoglobin
Changes of fasting glycated hemoglobin
Measured: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
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.
Measured: baseline, 3rd month, 6th month, 9thmonth, 12th month
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.
Measured: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Changes of brain hemodynamics detected by functional near-infrared spectroscope system
Changes of brain hemodynamics detected by functional near-infrared spectroscope system
Measured: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
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.
Measured: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
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.
Measured: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Change of Global Assessment Function
Change of Global Assessment Function (GAF), higher score means a better outcome.
Measured: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Jan 2024
- Primary completion1 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, The Affiliated Brain Hospital of Nanjing Medical University, Anhui Mental Health Center
- Responsible party
- Principal investigator, Renrong Wu, Central South University
- Investigators
- Renrong Wu, M.D., Ph.D., Study chair, Mental Health Institute of Second Xiangya Hospital,CSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123897
- Sponsor's protocol ID
- WU2023cohort
- Status last verified
- Nov 2024
- First submitted
- 16 Oct 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41568002
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Clinical Database and Biobank for Schizophrenia：A Cohort Study
- ClinicalTrials.gov ID
- NCT06123897
- Acronym / sponsor ID
- WU2023cohort
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Cohort Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, The Affiliated Brain Hospital of Nanjing Medical University, Anhui Mental Health Center
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with schizophrenia | – | Other: Regular follow-up assessments without intervention.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. |
| Healthy volunteers | – | Other: Cross-sectional assessment* 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be recruited from outpatient or inpatient departments.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular 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. | Other | Individuals with schizophrenia |
| Cross-sectional assessmentVolunteers 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. | Other | Healthy volunteers |
Primary outcome
Change of the MATRICS Consensus Cognitive Battery score
Time frame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
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).
Change of clinical symptoms by Positive And Negative Syndrome Scale
Time frame: baseline, half a month, 1st month, 3rd month, 6th month, 9thmonth, 12th month
The change of Positive And Negative Syndrome Scale at different follow up timepoint (lower score means a better outcome)
Change of clinical symptoms by Clinical Global Impression
Time frame: baseline, half a month, 1st month, 3rd month, 6th month, 9thmonth, 12th month
The change of Clinical Global Impression at different follow up timepoint (lower score means a better outcome)
12 secondary outcomes
Change of the level of blood lipids
Time frame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Change of Body Mass Index
Time frame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Change of waist-hip circumference
Time frame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Changes of the level of fasting blood glucose
Time frame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Changes of the level of fasting insulin
Time frame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Changes of the level of fasting glycated hemoglobin
Time frame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Changes of functional MRI
Time frame: baseline, 3rd month, 6th month, 9thmonth, 12th month
Changes of eye movement
Time frame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Changes of brain hemodynamics detected by functional near-infrared spectroscope system
Time frame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Change of electroencephalogram
Time frame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Change of social function by Personal and Social Performance Scale
Time frame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Change of Global Assessment Function
Time frame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Derived from this study: PubMed 41568002Yuan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Renrong Wu, M.D., Ph.D. study chair
Mental Health Institute of Second Xiangya Hospital,CSU
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Central South University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renrong Wu, M.D., Ph.D. (15874179855, wurenrong2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the MATRICS Consensus Cognitive Battery score (time frame: baseline, 1st month, 3rd month, 6th month, 9thmonth, 12th month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06123897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.