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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06370793
Other study ID # NBU-2024-011
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date December 31, 2026

Study information

Verified date April 2024
Source Ningbo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In recent years, the prevalence of severe mental disorders 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 severe mental disorders 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-diagnosis, diagnosis, follow-up, disease changes and death, realising full-cycle management of patients with severe mental disorders. Currently, NEED has accumulated data on more than 50,000 patients with severe mental disorders 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 57212
Est. completion date December 31, 2026
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Clinical diagnosis of schizophrenia (F20) - Clinical diagnosis of schizo-affective disorder (F25) - Clinical diagnosis of paranoid psychoses (F22) - Clinical diagnosis of bipolar disorder (F30-F31) - Clinical diagnosis of epileptic psychosis (F06.8) - Clinical diagnosis of mental retardation (F70-F79) Exclusion Criteria: - None.

Study Design


Intervention

Other:
Patient with severe mental disorder without intervention
Patients with severe mental disorders identified based on exposures of interest to the study

Locations

Country Name City State
China Ningbo Mental Health Information System Ningbo Zhejiang

Sponsors (2)

Lead Sponsor Collaborator
Ningbo University The Affiliated Kangning Hospital of Ningbo University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 severe mental disorders with those without severe mental disorders.
At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Primary 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 severe mental disorders with those without severe mental disorders.
At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Primary 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 severe mental disorders with those without severe mental disorders.
At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Primary 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 severe mental disorders with those without severe mental disorders.
At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Primary 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 severe mental disorders with those without severe mental disorders.
At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Primary 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 severe mental disorders with those without severe mental disorders.
At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Primary 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 severe mental disorders with those without severe mental disorders.
At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Primary 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 severe mental disorders with those without severe mental disorders. At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Primary 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 severe mental disorders with those without severe mental disorders.
At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Primary 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 severe mental disorders with those without severe mental disorders.
Recorded during the study period (2019-2023)
Primary 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 severe mental disorders with those without severe mental disorders.
Recorded during the study period (2019-2023)
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