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The purpose of this study is to compare the efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole | Active Comparator |
| |
| Ziprasidone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Oral aripiprazole capsules 15 mg once daily from Days 1-14; thereafter, doses could be adjusted on Days 14 and 21 to 10, 15, or 30 mg once daily; patients treated for 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores. | 28 days | |
| Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Positive and Negative Syndrome Scale (PANSS) positive subscale scores. | 28 days | |
| Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores. | 28 days |
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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 | Anaheim | California | 92804 | United States | ||
| Pfizer Investigational Site |
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| Ziprasidone | Drug | Oral ziprasidone capsules 40 mg twice daily on Day 1, 60 mg twice daily on Day 2, 80 mg twice daily on Days 3-14; thereafter, doses could be adjusted on Days 14 and 21 to 40, 60, or 80 mg twice daily; patients treated for 28 days |
|
| Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores. | 28 days |
| Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores. | 28 days |
| Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores. | 28 days |
| Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores. | 28 days |
| Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores. | 28 days |
| Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores. | 28 days |
| Change from baseline to endpoint in Patient Preference Scale (PPS) scores. | 28 days |
| Change from baseline to endpoint in Life Skills Profile (LSP). | 28 days |
| Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28. | 28 days |
| Change from baseline to endpoint in Cognitive Battery. | 28 days |
| Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores. | 28 days |
| Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Clinical Global Impressions-Improvement (CGI-I) scale scores. | 28 days |
| Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28. | 28 days |
| Change from baseline to Day 28 in movement disorder rating scale scores. | 28 days |
| Cerritos |
| California |
| 90703 |
| United States |
| Pfizer Investigational Site | Culver City | California | 90232 | United States |
| Pfizer Investigational Site | Garden Grove | California | 92845 | United States |
| Pfizer Investigational Site | Glendale | California | 91206 | United States |
| Pfizer Investigational Site | La Mesa | California | 91942 | United States |
| Pfizer Investigational Site | Newport Beach | California | 92663 | United States |
| Pfizer Investigational Site | Paramount | California | 90723 | United States |
| Pfizer Investigational Site | Riverside | California | 92506 | United States |
| Pfizer Investigational Site | San Diego | California | 92105 | United States |
| Pfizer Investigational Site | San Diego | California | 92123 | United States |
| Pfizer Investigational Site | San Diego | California | 92126 | United States |
| Pfizer Investigational Site | Torrance | California | 90505 | United States |
| Pfizer Investigational Site | Upland | California | 91786 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20016 | United States |
| Pfizer Investigational Site | Hialeah | Florida | 33016 | United States |
| Pfizer Investigational Site | Shreveport | Louisiana | 71101 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21202 | United States |
| Pfizer Investigational Site | Rockville | Maryland | 20850 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63104 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63118 | United States |
| Pfizer Investigational Site | Clementon | New Jersey | 08021 | United States |
| Pfizer Investigational Site | Princeton | New Jersey | 08540 | United States |
| Pfizer Investigational Site | Willingboro | New Jersey | 08046 | United States |
| Pfizer Investigational Site | Woodlane | New Jersey | 08060 | United States |
| Pfizer Investigational Site | Jamaica | New York | 11418 | United States |
| Pfizer Investigational Site | Staten Island | New York | 10305 | United States |
| Pfizer Investigational Site | Butner | North Carolina | 27509 | United States |
| Pfizer Investigational Site | Chapel Hill | North Carolina | 27599-7160 | United States |
| Pfizer Investigational Site | Durham | North Carolina | 27705 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27603 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45220 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45267-0559 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73118 | United States |
| Pfizer Investigational Site | Bellaire | Texas | 77401 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75228 | United States |
| Pfizer Investigational Site | Houston | Texas | 77008 | United States |
| Pfizer Investigational Site | Irving | Texas | 75062 | United States |
| Pfizer Investigational Site | Arlington | Virginia | 22204 | United States |
| Pfizer Investigational Site | Arlington | Virginia | 22205 | United States |
| Pfizer Investigational Site | Falls Church | Virginia | 22041 | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| C092292 | ziprasidone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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