Ningbo Severe Mental Disorders Cohort

Schizophrenia Clinical Trial

— NEED  

Official title:

Ningbo Severe Mental Disorders Cohort, a Longitudinal Population-based Ambispective Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06370793
• Other study ID #: NBU-2024-011
• Status: Active, not recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Affective Disorders, Psychotic
• Bipolar Disorder
• Intellectual Disability
• Mental Disorders
• Mental Retardation
• Psychotic Disorders
• Schizophrenia
• Severe Mental Disorder

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)