Clinical trial NCT06370793: Ningbo Schizophrenia Cohort
Official title: Ningbo Schizophrenia Cohort, a Longitudinal Population-based Ambispective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Schizophrenia
Keywords: Population-based healthcare database
Longitudinal study
Ambispective Cohort
Schizophrenia
Lead sponsor: Ningbo University
Sponsor class: OTHER
Collaborators: name: The Affiliated Kangning Hospital of Ningbo University
First posted: 2024-04-17
Enrollment: 26899
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None.

Primary outcomes:
measure: Risk of circulatory system diseases
timeFrame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
measure: Risk of endocrine system diseases
timeFrame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
measure: Risk of pulmonary system and allergy diseases
timeFrame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
measure: Risk of gastrointestinal system diseases
timeFrame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
measure: Risk of musculoskeletal system diseases
timeFrame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
measure: Risk of urogenital system diseases
timeFrame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
measure: Risk of hematological system diseases
timeFrame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
measure: Risk of cancers
timeFrame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
measure: Risk of neurological system diseases
timeFrame: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)
measure: Risk of suicide
timeFrame: Recorded during the study period (2019-2023)
measure: Risk of violence
timeFrame: Recorded during the study period (2019-2023)
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo University
state: Zhejiang
Study officials:
References: