SchizophreniaNCT05159349
Mental Health During the Whole Life Cycle of Community Patients With Schizophrenia
An observational study of Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- Aged between 18 and 65 years.
Who cannot join
- Patients with severe physical diseases and organic brain diseases.
- The patient is about to settle outside Shanghai.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai
Jun Cai, 86-18017311058, caijun533@163.com
About this study
Official title: Mental Health During the Whole Life Cycle of Community Patients With Schizophrenia: a Cohort Study
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.
Read the detailed description
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.
- Study design 3.1 Pay attention to multiple prognostic outcomes such as relapse, dangerous behaviours, suicide and self-harm, calculate the included sample size based on this. After the start of the project, in Hongkou, Jinshan, Minhang, and Xuhui districts, all schizophrenic patients in management who meet the inclusion criteria will be continuously included in the district.
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.
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Cohort study, The whole life cycle, Mental health
- Medical subject headings
- Schizophrenia, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | Not described | |
| Non-exposed group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline BPRS at 12 months
2-year BPRS reduction rate
The BPRS reduction rate during the 2-year follow-up period.
Measured: Change from Baseline BPRS at 24 months
3-year BPRS reduction rate
The BPRS reduction rate during the 3-year follow-up period.
Measured: Change from Baseline BPRS at 36 months
4-year BPRS reduction rate
The BPRS reduction rate during the 4-year follow-up period.
Measured: Change from Baseline BPRS at 48 months
5-year BPRS reduction rate
The BPRS reduction rate during the 5-year follow-up period.
Measured: Change from Baseline BPRS at 60 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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.
Measured: 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.
Measured: Change from Baseline SDSS at 12 months,24 months, 36 months, 48 months, and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start1 Dec 2021
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Jun Cai, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159349
- Sponsor's protocol ID
- Jun-Cai
- Status last verified
- Jun 2026
- First submitted
- 10 Nov 2021
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health During the Whole Life Cycle of Community Patients With Schizophrenia: a Cohort Study
- ClinicalTrials.gov ID
- NCT05159349
- Acronym / sponsor ID
- Jun-Cai
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Cohort study, The whole life cycle, Mental health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- Study design 3.1 Pay attention to multiple prognostic outcomes such as relapse, dangerous behaviours, suicide and self-harm, calculate the included sample size based on this. After the start of the project, in Hongkou, Jinshan, Minhang, and Xuhui districts, all schizophrenic patients in management who meet the inclusion criteria will be continuously included in the district.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | – |
| Non-exposed group | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
- Aged between 18 and 65 years.
Key exclusion criteria (2 listed)
- Patients with severe physical diseases and organic brain diseases.
- The patient is about to settle outside Shanghai.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1-year BPRS reduction rate
Time frame: Change from Baseline BPRS at 12 months
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.
2-year BPRS reduction rate
Time frame: Change from Baseline BPRS at 24 months
The BPRS reduction rate during the 2-year follow-up period.
3-year BPRS reduction rate
Time frame: Change from Baseline BPRS at 36 months
The BPRS reduction rate during the 3-year follow-up period.
4-year BPRS reduction rate
Time frame: Change from Baseline BPRS at 48 months
The BPRS reduction rate during the 4-year follow-up period.
5-year BPRS reduction rate
Time frame: Change from Baseline BPRS at 60 months
The BPRS reduction rate during the 5-year follow-up period.
6 secondary outcomes
MOAS
Time frame: Change from Baseline MOAS at 12 months, 24 months, 36 months, 48 months, and 60 months
WHOQOL-BREF
Time frame: Change from Baseline WHOQOL-BREF at 12 months, 24 months, 36 months, 48 months, and 60 months
GAD-7
Time frame: Change from Baseline GAD-7 at 12 months, 24 months, 36 months, 48 months, and 60 months
PHQ-9
Time frame: Change from Baseline PHQ-9 at 12 months, 24 months, 36 months, 48 months, and 60 months
PSQI
Time frame: Change from Baseline PSQI at 12 months, 24 months, 36 months, 48 months, and 60 months
SDSS
Time frame: Change from Baseline SDSS at 12 months,24 months, 36 months, 48 months, and 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Cai study director
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weibo Zhang (86-18918516651, zhangweibo600@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year BPRS reduction rate (time frame: Change from Baseline BPRS at 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.