Mental Health During the Whole Life Cycle of Community Patients with Schizophrenia

NCT05159349 | Recruiting DMC

• 1 other identifier: Jun-Cai
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

Schizophrenia is one of the components of severe mental disorders. It has the characteristics of prolonged course, low cure rate, high recurrence rate and high disability rate. It brings many short-term and long-term effects to individuals, families and society. Studies on patients with schizophrenia mainly focus on cross-sectional and case-control studies, but there is a lack of long-term follow-up of patients with schizophrenia in the community. Therefore, this study would establish a cohort study to solve the chronological relationship between exposure and effect, focus on community schizophrenia, and establish a community schizophrenia patient biobank that has been tracked for a long time from diagnosis.

Conditions

Schizophrenia

Keywords

Schizophrenia; Cohort study; The whole life cycle; Mental health

Outcome Measures

Primary Outcomes (4)

• 1-year BPRS reduction rate

  The Brief Psychiatric Rating Scale (BPRS) was used to measure the presence and severity of psychiatric symptoms entailing positive symptoms, general psychopathology, and affective symptoms (e.g., thought disturbance, emotional withdrawal, hostility, and suspiciousness) for patients with mental illness, particularly schizophrenia. Each of the 18 items are designed to represent a discrete symptom area. Items are rated on a 7-point Likert scale, from 1 = "not present" to 7 = "extremely severe", with scores ranging from 18 to 126 (achieved through summing the item scores). Higher scores indicated more severity of psychiatric symptoms. Reduction rate was calculated using the following formula: reduction rate= (Score before treatment - Score after treatment)/(Score before treatment - 18) × 100%. A reduction rate of BPRS score \> 25% was considered as a clinically meaningful improvement.

  Change from Baseline BPRS at 12 months

• 2-year BPRS reduction rate

  The BPRS reduction rate during the 2-year follow-up period.

  Change from Baseline BPRS at 24 months

• 3-year BPRS reduction rate

  The BPRS reduction rate during the 3-year follow-up period.

  Change from Baseline BPRS at 36 months

• 4-year BPRS reduction rate

  The BPRS reduction rate during the 4-year follow-up period.

  Change from Baseline BPRS at 48 months

Secondary Outcomes (24)

• 1-year MOAS

  Change from Baseline MOAS at 12 months

• 2-year MOAS

  Change from Baseline MOAS at 24 months

• 3-year MOAS

  Change from Baseline MOAS at 36 months

• 4-year MOAS

  Change from Baseline MOAS at 48 months

• 1-year WHOQOL-BREF

  Change from Baseline WHOQOL-BREF at 12 months

Other Outcomes (12)

• 1-year Rate of rehospitalization

  The rehospitalization rate from Baseline during the 1-year follow-up period.

• 2-year Rate of rehospitalization

  From Baseline during the 2-year follow-up period.

• 3-year Rate of rehospitalization

  From Baseline during the 3-year follow-up period.

Study Arms (2)

Exposed group

Non-exposed group

Eligibility Criteria

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

Study Population

Since the start of the project, all schizophrenia patients in management who meet the inclusion criteria in this district have been continuously included in Hongkou, Jinshan, Minhang, and Xuhui districts, and at least 300 patients in each district will be included until the corresponding sample size is reached.

You may qualify if:

• Registered in the Shanghai Mental Health Information Management System.
• Meets criteria for the diagnosis of schizophrenia (ICD-10 or ICD-11).
• Patients with schizophrenia diagnosed within five years.
• Age 18 years or older.

You may not qualify if:

• Patients with severe physical diseases and organic brain diseases.
• The patient is about to settle outside Shanghai.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Fudan University: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Proteomics: collecting peripheral blood(5ml), once a year. 2. Genomics: collecting peripheral blood( 2ml), collected at enrollment.

MeSH Terms

Conditions

Schizophrenia; Psychological Well-Being

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Jun Cai

  Shanghai Mental Health Center

  STUDY DIRECTOR

Central Study Contacts

Weibo Zhang

CONTACT

86-18918516651; zhangweibo600@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 16, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)