SchizophreniaNSCNCT06370793
Ningbo Schizophrenia Cohort
An observational study of Schizophrenia, run by Ningbo University at 1 site in China.
Trial summary
In recent years, the prevalence of schizophrenia in China has continued to grow, and the burden of disease in society has continued to rise. In order to improve the prognosis of patients with schizophrenia and reduce the risk of disease relapse or readmission, researchers established a cohort based on the Ningbo… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Patient with schizophrenia without intervention
- How many people
- 26,899 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 31 Dec 2026
- How long will I take part?
- 20 Years
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were eligible if they were aged 18-65 years at diagnosis and had a diagnosis of schizophrenia confirmed by at least two independent visit records in the EHR. Additionally, they were required to provide signed informed consent, either personally or through their legal representatives, and possess complete electronic health records, including date of birth, gender, and a valid medical identifier. Subjects meeting any of the following criteria were not eligible to participate: (1) history of severe neurological diseases, including epilepsy, encephalitis, or brain tumours or (2) history of severe head trauma resulting in unconsciousness, to exclude trauma-induced psychotic symptoms.
Who may be able to join
- Clinical diagnosis of schizophrenia (F20)
- Aged 18-65 years at the time of diagnosis
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ningbo Schizophrenia Cohort, a Longitudinal Population-based Ambispective Cohort Study
In recent years, the prevalence of schizophrenia in China has continued to grow, and the burden of disease in society has continued to rise. In order to improve the prognosis of patients with schizophrenia and reduce the risk of disease relapse or readmission, researchers established a cohort based on the Ningbo Mental Health Information System in Ningbo, a sub-provincial city in the southern wing of the Yangtze River Delta of China, with a resident population of more than 9 million, and linked it to the residents' health records, and through the data linkage obtained data on patients in the full cycle of pre-onset, diagnosis, follow-up, disease changes and death, realising full-cycle management of patients with schizophrenia.
Currently, NSC has accumulated data on more than 30,000 patients with schizophrenia and obtained multi-dimensional longitudinal information through long-term follow-up and data linkage. All diseases follow the World Health Organization International Classification of Diseases 10th Edition (ICD-10) for clinical coding, and available data include baseline demographics, past history, family history, social functioning deficit screening scale scores, risk assessment, and so on and longitudinal health information from electronic health records (EHR), providing a solid data base for future real-world studies.
- Conditions
- Schizophrenia
- Being tested
- Patient with schizophrenia without intervention
- Keywords
- Population-based healthcare database, Longitudinal study, Ambispective Cohort, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient with schizophrenia without interventionOther
Patients with schizophrenia identified based on exposures of interest to the study
| Study group | Role | What they receive |
|---|---|---|
| Patients with Schizophrenia | Not described Receives: Other: Patient with schizophrenia without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of circulatory system diseases
At least one of the following diagnoses in the electronic health records : Primary hypertension (I10), Cerebral infarction (I63), Transient cerebral ischaemic attacks and related syndromes (G45), Intracerebral haemorrhage (I61), Subarachnoid haemorrhage (I60), Hemorrhagic stroke (I60-I61), Stroke (I60-I64, I69), Pulmonary embolism (I26), Aortic aneurysm and dissection (I71), Cardiovascular disease (I20-I25), Atrial fibrillation (I48), Cardiomyopathy (I42), Peripheral vascular diseases (I73), Myocardial infarction (I21-I22), Heart failure (I50).
Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Measured: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
Risk of endocrine system diseases
At least one of the following diagnoses in the electronic health records : Diabetes mellitus (E10-E14), Thyroid disorder (E00-E05, E61-E69, E07), Gout (E79, M10).
Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Measured: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
Risk of pulmonary system and allergy diseases
At least one of the following diagnoses in the electronic health records : Chronic pulmonary disease (J40-J47), Allergy (J30.1-J30.4, L23, L50.0, T78.0, T78.2, T78.4).
Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Measured: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
Risk of gastrointestinal system diseases
At least one of the following diagnoses in the electronic health records : Ulcer/chronic gastritis (K22.1, K25-K28, K29.3-K29.5), Chronic liver disease (B16-B19, K70, K74, K76.6, I85), Inflammatory bowel disease (K50-K51), Diverticular disease of intestine (K57).
Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Measured: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
Risk of musculoskeletal system diseases
At least one of the following diagnoses in the electronic health records :Connective tissue disorders (M05-M06, M08-M09, M30-M36, D86), Osteoporosis (M80-M82).
Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Measured: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
Risk of urogenital system diseases
At least one of the following diagnoses in the electronic health records : Chronic kidney disease (N03, N11, N18-N19), Prostate disorders (N40).
Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Measured: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
Risk of hematological system diseases
At least one of the following diagnoses in the electronic health records : HIV/AIDS (B20-B24), Anemias (D50-D53, D55-D59, D60-D61, D63-D64).
Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Measured: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
Risk of cancers
Diagnosed with cancer (C00-C43, C45-C97) in electronic health records. Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Measured: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
Risk of neurological system diseases
At least one of the following diagnoses in the electronic health records :Vision problem (H40, H25, H54), Hearing problem (H90-H91, H93.1), Migraine (G43), Epilepsy (G40-G41), Parkinson's disease (G20-G22), Multiple sclerosis (G35), Neuropathies (G50-G64).
Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Measured: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
Risk of suicide
At least one of the following records in the Ningbo Mental Health Information System: attempted suicide, suicide, death by suicide.
Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Measured: Recorded during the study period (2019-2023)
Risk of violence
At least one of the following records in the Ningbo Mental Health Information System: causing trouble, causing an accident, committing an offence, injuring another person.
Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Measured: Recorded during the study period (2019-2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jul 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2026 (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
- 26,899 participants (actual)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Ningbo University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Kangning Hospital of Ningbo University
- Responsible party
- Principal investigator, Liya Liu, Ningbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370793
- Sponsor's protocol ID
- NBU-2024-011
- Acronym
- NSC
- Status last verified
- May 2025
- First submitted
- 12 Apr 2024
- Last updated
- 23 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ye H, Zhao Y, Li L, Qian Y, Zhu H, Bian G, Liu L. Ningbo Schizophrenia Cohort (NSC)-a longitudinal ambispective cohort based on electronic health records: cohort profile. BMJ Open. 2025 May 15;15(5):e091188. doi: 10.1136/bmjopen-2024-091188.
PubMed 40379328
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ningbo Schizophrenia Cohort, a Longitudinal Population-based Ambispective Cohort Study
- ClinicalTrials.gov ID
- NCT06370793
- Acronym / sponsor ID
- NSC / NBU-2024-011
- Conditions
- Schizophrenia
- Keywords
- Population-based healthcare database, Longitudinal study, Ambispective Cohort, Schizophrenia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 26,899 participants (actual)
- Lead sponsor
- Ningbo UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Kangning Hospital of Ningbo University
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Apr 2024 (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.
In recent years, the prevalence of schizophrenia in China has continued to grow, and the burden of disease in society has continued to rise. In order to improve the prognosis of patients with schizophrenia and reduce the risk of disease relapse or readmission, researchers established a cohort based on the Ningbo Mental Health Information System in Ningbo, a sub-provincial city in the southern wing of the Yangtze River Delta of China, with a resident population of more than 9 million, and linked it to the residents' health records, and through the data linkage obtained data on patients in the full cycle of pre-onset, diagnosis, follow-up, disease changes and death, realising full-cycle management of patients with schizophrenia.
Currently, NSC has accumulated data on more than 30,000 patients with schizophrenia and obtained multi-dimensional longitudinal information through long-term follow-up and data linkage. All diseases follow the World Health Organization International Classification of Diseases 10th Edition (ICD-10) for clinical coding, and available data include baseline demographics, past history, family history, social functioning deficit screening scale scores, risk assessment, and so on and longitudinal health information from electronic health records (EHR), providing a solid data base for future real-world studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Schizophrenia | – | Other: Patient with schizophrenia without intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were eligible if they were aged 18-65 years at diagnosis and had a diagnosis of schizophrenia confirmed by at least two independent visit records in the EHR. Additionally, they were required to provide signed informed consent, either personally or through their legal representatives, and possess complete electronic health records, including date of birth, gender, and a valid medical identifier. Subjects meeting any of the following criteria were not eligible to participate: (1) history of severe neurological diseases, including epilepsy, encephalitis, or brain tumours or (2) history of severe head trauma resulting in unconsciousness, to exclude trauma-induced psychotic symptoms.
Key inclusion criteria (2 listed)
- Clinical diagnosis of schizophrenia (F20)
- Aged 18-65 years at the time of diagnosis
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Patient with schizophrenia without interventionPatients with schizophrenia identified based on exposures of interest to the study | Other | Patients with Schizophrenia |
Primary outcome
Risk of circulatory system diseases
Time frame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
At least one of the following diagnoses in the electronic health records : Primary hypertension (I10), Cerebral infarction (I63), Transient cerebral ischaemic attacks and related syndromes (G45), Intracerebral haemorrhage (I61), Subarachnoid haemorrhage (I60), Hemorrhagic stroke (I60-I61), Stroke (I60-I64, I69), Pulmonary embolism (I26), Aortic aneurysm and dissection (I71), Cardiovascular disease (I20-I25), Atrial fibrillation (I48), Cardiomyopathy (I42), Peripheral vascular diseases (I73), Myocardial infarction (I21-I22), Heart failure (I50). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Risk of endocrine system diseases
Time frame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
At least one of the following diagnoses in the electronic health records : Diabetes mellitus (E10-E14), Thyroid disorder (E00-E05, E61-E69, E07), Gout (E79, M10). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Risk of pulmonary system and allergy diseases
Time frame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
At least one of the following diagnoses in the electronic health records : Chronic pulmonary disease (J40-J47), Allergy (J30.1-J30.4, L23, L50.0, T78.0, T78.2, T78.4). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Risk of gastrointestinal system diseases
Time frame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
At least one of the following diagnoses in the electronic health records : Ulcer/chronic gastritis (K22.1, K25-K28, K29.3-K29.5), Chronic liver disease (B16-B19, K70, K74, K76.6, I85), Inflammatory bowel disease (K50-K51), Diverticular disease of intestine (K57). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Risk of musculoskeletal system diseases
Time frame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
At least one of the following diagnoses in the electronic health records :Connective tissue disorders (M05-M06, M08-M09, M30-M36, D86), Osteoporosis (M80-M82). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Risk of urogenital system diseases
Time frame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
At least one of the following diagnoses in the electronic health records : Chronic kidney disease (N03, N11, N18-N19), Prostate disorders (N40). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Risk of hematological system diseases
Time frame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
At least one of the following diagnoses in the electronic health records : HIV/AIDS (B20-B24), Anemias (D50-D53, D55-D59, D60-D61, D63-D64). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Risk of cancers
Time frame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
Diagnosed with cancer (C00-C43, C45-C97) in electronic health records. Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Risk of neurological system diseases
Time frame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
At least one of the following diagnoses in the electronic health records :Vision problem (H40, H25, H54), Hearing problem (H90-H91, H93.1), Migraine (G43), Epilepsy (G40-G41), Parkinson's disease (G20-G22), Multiple sclerosis (G35), Neuropathies (G50-G64). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Risk of suicide
Time frame: Recorded during the study period (2019-2023)
At least one of the following records in the Ningbo Mental Health Information System: attempted suicide, suicide, death by suicide. Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
Risk of violence
Time frame: Recorded during the study period (2019-2023)
At least one of the following records in the Ningbo Mental Health Information System: causing trouble, causing an accident, committing an offence, injuring another person. Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.
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 23 May 2025.
- Derived from this study: PubMed 40379328Ye H, Zhao Y, Li L, Qian Y, Zhu H, Bian G, Liu L. Ningbo Schizophrenia Cohort (NSC)-a longitudinal ambispective cohort based on electronic health records: cohort profile. BMJ Open. 2025 May 15;15(5):e091188. doi: 10.1136/bmjopen-2024-091188.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Ningbo University at 1 site 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 1 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: under way, not looking for participants, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of circulatory system diseases (time frame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)). The study lists 11 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 NCT06370793, 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 23 May 2025.