Ningbo Schizophrenia Cohort

NCT06370793 | Active Not Recruiting

• 1 other identifier: NBU-2024-011
• Study Type: observational
• Target: 26,899
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Population-based healthcare database; Longitudinal study; Ambispective Cohort; Schizophrenia

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Recorded during the study period (2019-2023)

Study Arms (1)

Patients with Schizophrenia

Other: Patient with schizophrenia without intervention

Interventions

Patient with schizophrenia without intervention OTHER

Patients with schizophrenia identified based on exposures of interest to the study

Patients with Schizophrenia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Clinical diagnosis of schizophrenia (F20)
• Aged 18-65 years at the time of diagnosis

You may not qualify if:

• None.

Sponsors & Collaborators

• Ningbo University: lead
• The Affiliated Kangning Hospital of Ningbo University: collaborator

Study Sites (1)

Ningbo University

Ningbo, Zhejiang, 315000, China

Location

Related Publications (1)

• 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.

  PMID: 40379328 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Methods

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: July 1, 2018
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

CN (1)