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The purpose of this study is to compare the efficacy and safety of ziprasidone and risperidone for the treatment of schizophrenia in Chinese patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug | Oral risperidone capsules 1 and 2 mg; doses were 1 mg once daily on Days 1-2, 2 mg once daily on Days 3-4, 3 mg once daily on Days 5-7, and 1, 2, or 3 mg twice daily during Weeks 2-6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, laboratory test changes, movement disorder scale scores | Weeks 1, 2, 4, and 6 | |
| Change from baseline in PANSS negative subscale score | Weeks 1, 2, 4, and 6 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Beijing | 100083 | China | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Ziprasidone | Drug | Oral ziprasidone capsules 40, 60, and 80 mg; doses were 40 mg twice daily on Days 1-2, 60 mg twice daily on Days 3-7, and 40, 60, or 80 mg twice daily during Weeks 2-6 |
|
| Change from baseline in PANSS general psychopathology subscale score |
| Weeks 1, 2, 4, and 6 |
| PANSS responder rate | Weeks 1, 2, 4 and 6 |
| Clinical Global Impression-Severity (CGI-S) score | Baseline and Weeks 1, 2, 4, and 6 |
| Change from baseline in Brief Psychiatric Rating Scale derived (BPRSd) score | Weeks 1, 2, 4, and 6 |
| Change from baseline in PANSS positive subscale score | Weeks 1, 2, 4, and 6 |
| Clinical Global Impression-Improement (CGI-I) score | Weeks 1, 2, 4, and 6 |
| Beijing |
| 100088 |
| China |
| Pfizer Investigational Site | Guangzhou | 510370 | China |
| Pfizer Investigational Site | Nanjing | 210029 | China |
| Pfizer Investigational Site | Shanghai | 200030 | China |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| C092292 | ziprasidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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