An Observational Study on Atypical Antipsychotics Long-term Treatment Patients With Schizophrenia

Study Overview
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Brief Summary
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This multi-centre study will evaluate the safety and related factors study of atypical antipsychotics long-term treatment in Chinese Patients with Schizophrenia. The atypical antipsychotics include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone , amisulpride , perospirone and clozapine. This is an open, cohort, multi-center observational clinical study. The main purpose is to evaluate the safety. And the second purpose is to evaluate the efficacy of atypical antipsychotics. The efficacy evaluations include symptoms, social function, recurrence rate and hospitalization. This study belongs to IV period post-marketing drugs research. Planned sample size is 3000 cases. Visits occurs at 0,4,8,13,26,52,78,104,130 and 156 weeks. The main indexes include physical examination, vital signs, abdominal circumference , laboratory tests (blood cell analysis/ blood biochemical tests / prolactin (PRL) / thyroxine, etc.), adverse events, 12-lead electrocardiogram( ECG), extrapyramidal syndrome(EPS )assessment, sexual function evaluation, medication and other subjective feelings. The second indexes include scales of Positive and Negative Syndrome Scale(PANSS)，Clinical Global Impression-severity of Illness Scale(CGI-S), Calgary Depression Scale for Schizophrenia(CDSS),Personal and Social Performance Scale(PSP), the MOS 36一item Short Form Health Survey(SF-36), relapse rate, drug consolidation, medical-related expenses, income, drug plasma concentration and genetic information.

Conditions
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Schizophrenia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An in-patient or out-patient (male or female) and aged ≥18 years A diagnosis of schizophrenia,DSM-IV(Diagnostic and Statistical Manual Diploma in Social Medicine-IV) Subjects must have the ability to effectively communicate with investigator,complete study related documents, comprehend the key components of the consent form and must provide written informed consent to participate in the study prior to any study specific assessments or procedures. Patients are taking or will take atypical antipsychotics which include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone , amisulpride , perospirone and clozapine Exclusion Criteria: Participation in other clinical studies. Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Systolic Blood Pressure | Measure blood pressure at 156 weeks | at 156 weeks | 
| Change from Baseline liver function | Measure blood biochemical tests at 156 weeks | at 156 weeks | 
| Change from Baseline PRL | Measure PRL level at 156 weeks | at 156 weeks | 
| Change from Baseline thyroxine | thyroxine laboratory tests at 156 weeks | at 156 weeks | 
| Number of Participants with EPS | EPS assessment at 156 weeks | at 156 weeks | 
| Number of Participants with abnormal ECG | ECG examination at 156 weeks | at 156 weeks | 
| Number of participants with abnormal sexual function | sexual function evaluation medication at 156 weeks | at 156 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline deduction of PANSS | PANSS assessment at 156 weeks | at 156 weeks | 
| Change from Baseline deduction of CGI-S | CGI-S assessment at 156 weeks | at 156 weeks | 
| Change from Baseline deduction of CDSS | CDSS assessment at 156 weeks | at 156 weeks | 
| Change from Baseline deduction of PSP | PSP assessment at 156 weeks | at 156 weeks |