An observational study in Schizophrenia, sponsored by Shanghai Mental Health Center. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Shanghai Mental Health Center · Observational
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.
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.
Aim of the study:
1.1 Based on previous studies, this study will focus on patients with schizophrenia in the community. Establishing a biobank of new cases to monitor the occurrence of disease recurrences, violent behaviours and other outcome events during the whole life cycle of schizophrenia patients. Exploring the predictive effects of biological, psychosocial, imaging and other indicators on patient recurrence and other events.
1.2 At the same time, establishing a sample database of patients with schizophrenia in the community to lay a working foundation and reserve sample resources for subsequent related mechanism research, drug research, and intervention research.
Content of the study 2.1 At least 1,200 patients with schizophrenia diagnosed within five years will be recruited. On the basis of community follow-up and health examination, this study will expand biological sample collection and professional scale evaluation, establish a schizophrenia community cohort.
2.2 Based on the establishment of the cohort, this study will carry out statistical description according to the type of data. The differences will be compared between the exposed group and the unexposed group in demographic information, family and past disease history, personal living habits, condition and treatment, psychological evaluation, social support evaluation, sleep quality, functional evaluation, quality of life and other content. Repeated measures analysis of variance will be used to compare the differences in blood pressure, blood glucose and other indicators between the exposed group and the unexposed group. The generalized estimating equation will be used to analyze the relationship between the outcome of recurrence and emergency about physical activity, related biochemical indicators, and social support. On the basis of statistical results, this study will carry out research on the prognostic factors and related physiological mechanisms of schizophrenia.
3.2 At baseline, the patient's demographic information and a complete health history (include personal history, family history, and medical history) will be taken. The questionnaire survey includes the Brief Psychiatric Rating Scale (BPRS)，the Patient Health Questionnaire-9 (PHQ-9)，the Generalized Anxiety Disorder Screener (GAD-7), the Pittsburgh Sleep Quality Index (PSQI) , the WHO Quality of Life Scale-Brief (WHOQOL-BREF) , the Modified Overt Aggression Scale (MOAS), the 10-item social disability screening schedule (SDSS) and the Perceived social support scale(PSSS),etc. Within six months of the completion of the baseline survey, the district-level mental health center arranges for patients in the district to participate in physical examinations. All measures will be administered at baseline and 12, 24, 36 ,48 and 60 months follow-up except for the health history and PSSS, which will be administered only at baseline. Besides, the study will focus on the patients' recurrence events, violent behavior, various impacts on society and family, emergency response events, and prognosis by carrying out active follow-up every three months.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 178 across 491 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →Shanghai Mental Health Center is the lead sponsor of 267 studies on the registry; 93 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Time frame: Change from Baseline BPRS at 12 months
2-year BPRS reduction rate
The BPRS reduction rate during the 2-year follow-up period.
Time frame: Change from Baseline BPRS at 24 months
3-year BPRS reduction rate
The BPRS reduction rate during the 3-year follow-up period.
Time frame: Change from Baseline BPRS at 36 months
4-year BPRS reduction rate
The BPRS reduction rate during the 4-year follow-up period.
Time frame: Change from Baseline BPRS at 48 months
5-year BPRS reduction rate
The BPRS reduction rate during the 5-year follow-up period.
Time frame: Change from Baseline BPRS at 60 months
MOAS
The Modified Overt Aggression Scale (MOAS) is a four-part behavior rating scale used to evaluate and document the "frequency and severity" of aggressive episodes. The rating scale is made up of four categories; verbal aggression, aggression against objects, aggression against self, and aggression against others. Each category consists of five responses, which over time can track the patient's aggressive behavior. The MOAS is one of the most widely used measures for violence and aggression, with 4 items in total, 0\~4 points for each item.
Time frame: Change from Baseline MOAS at 12 months, 24 months, 36 months, 48 months, and 60 months
WHOQOL-BREF
The WHO Quality of Life Scale-Brief (WHOQOL-BREF) was developed by the Word Health Organisation as a quality of life assessment that would be applicable cross-culturally. It is a 26 item self report measure, especially useful for measuring outcomes with adults with a psychosocial disability. The WHOQOL-BREF measures four factors: physical health, psychological Health, social relationships, and environment. The total score is presented between 26 and 156, where higher scores represent higher levels of quality of life.
Time frame: Change from Baseline WHOQOL-BREF at 12 months, 24 months, 36 months, 48 months, and 60 months
GAD-7
The Generalized Anxiety Disorder Screener (GAD-7) is a brief, 7-item self-report measure for anxiety symptoms in adolescents and adults. Although developed primarily as a screening tool for GAD, it can also be used as a diagnostic tool to monitor changes in symptoms over time, and as a screener for social anxiety, panic disorder, and post-traumatic stress disorder. Each item is rated on a likert-type scale from zero ("not at all") to three ("nearly every day"), with total scores ranging from 0 to 21.
Time frame: Change from Baseline GAD-7 at 12 months, 24 months, 36 months, 48 months, and 60 months
PHQ-9
The Patient Health Questionnaire-9 (PHQ-9) is a multipurpose instrument for screening , diagnosing , monitoring and measuring the severity of depression. The tool rates the frequency of the symptoms which factors into the scoring severity index. The PHQ -9 is brief and useful in clinical practice. The PHQ -9 can be administered repeatedly , which can reflect improvement or worsening of depression in response to treatment .Each item is rated on a likert-type scale from zero ("not at all") to three ("nearly every day").
Time frame: Change from Baseline PHQ-9 at 12 months, 24 months, 36 months, 48 months, and 60 months
PSQI
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. The questionnaire consists of a combination of Likert- type and open-ended questions. Respondents are asked to indicate how frequently they have experienced certain sleep difficulties over the past month and to rate their overall sleep quality. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances.
Time frame: Change from Baseline PSQI at 12 months, 24 months, 36 months, 48 months, and 60 months
SDSS
The 10-item social disability screening schedule (SDSS) was used for measuring social function. It is a shortened version of psychiatric disability assessment schedule (DAS). SDSS was used to evaluate social disability, with 10 items in total, 0\~2 points for each item.
Time frame: Change from Baseline SDSS at 12 months，24 months, 36 months, 48 months, and 60 months
1-year Rate of rehospitalization
Relapse of patients with schizophrenia is defined as a clinical deterioration or an exacerbation of symptoms based on rehospitalization. Data from the Shanghai Mental Health Work Website.
Time frame: The rehospitalization rate from Baseline during the 1-year follow-up period.
2-year Rate of rehospitalization
The rehospitalization rate from Baseline during the 2-year follow-up period.
Time frame: From Baseline during the 2-year follow-up period.
3-year Rate of rehospitalization
The rehospitalization rate from Baseline during the 3-year follow-up period.
Time frame: From Baseline during the 3-year follow-up period.
4-year Rate of rehospitalization
The rehospitalization rate from Baseline during the 4-year follow-up period.
Time frame: From Baseline during the 4-year follow-up period.
5-year Rate of rehospitalization
The rehospitalization rate from Baseline during the 5-year follow-up period.
Time frame: From Baseline during the 5-year follow-up period.
1-year the number of violent incidents
The primary health provider will follow up the patients every 3 months. If they learn about the violent behavior of the patient with schizophrenia during the follow-up process, they will record them on the Shanghai Mental Health Work Website.
Time frame: From Baseline during the 1-year follow-up period.
2-year the number of violent incidents
2-year the number of violent incidents
Time frame: From Baseline during the 2-year follow-up period.
3-year the number of violent incidents
3-year the number of violent incidents
Time frame: From Baseline during the 3-year follow-up period.
4-year the number of violent incidents
4-year the number of violent incidents
Time frame: From Baseline during the 4-year follow-up period.
5-year the number of violent incidents
5-year the number of violent incidents
Time frame: From Baseline during the 5-year follow-up period.
1-year the number of suicides
The primary health provider will follow up the patients every 3 months. If they learn about the suicide in individuals with schizophrenia during the follow-up process, they will record them on the Shanghai Mental Health Work Website.
Time frame: From Baseline during the 1-year follow-up period.
2-year the number of suicides
2-year the number of suicides
Time frame: From Baseline during the 2-year follow-up period.
3-year the number of suicides
3-year the number of suicides
Time frame: From Baseline during the 3-year follow-up period.
4-year the number of suicides
4-year the number of suicides
Time frame: From Baseline during the 4-year follow-up period.
5-year the number of suicides
5-year the number of suicides
Time frame: From Baseline during the 5-year follow-up period.
Plan to share: No
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