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The purpose of this study is to compare the efficacy and safety of ziprasidone and clozapine in schizophrenic patients who are resistant and/or intolerant to antipsychotic treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clozapine | Drug | Clozapine 25 or 100 mg tablets. Patients were initially titrated over the first 10 days to 300 mg/day and remained at this dose for 1 week. Thereafter, the dose could be varied between 250 and 600 mg/day based on response and tolerability for a total treatment duration of 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores | Until Final Visit (within 18 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders, based on change from baseline to endpoint in PANSS total score | Until Final Visit (within 18 weeks) | |
| Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores | Baseline and weekly from Weeks 1-18 |
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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 | Città di Castello | Perugia | 06012 | Italy | ||
| 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 | Ziprasidone 40, 60, or 80 mg capsules. Patients were initially titrated over the first 3 days to 80 mg/day, which could subsequently be increased to between 80 and 160 mg/day based on response and tolerability for a total treatment duration of 18 weeks |
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|
| Time to discontinuation | Up to 18 weeks |
| Change from baseline to endpoint in cognitive function assessments, including Rey serial verbal learning test, Stroop Color Word test, and Trail Making Test | Baseline and Weeks 12 and 18 |
| Change from baseline to endpoint in Global Assessment of Functioning (GAF) scores | Baseline and Week 8, 12, and 18 |
| Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores | Baseline and Weeks 4, 8, 12, and 18 |
| Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores | Screening and Weeks 1, 8, 12, and 18 |
| Change from baseline to endpoint in PANSS subscale scores | Baseline and weekly from Weeks 1-18 |
| Adverse events | Weekly from Weeks 1-18 |
| Change from baseline to endpoint in Calgary Depression Scale (CDSS) scores | Baseline and Weeks 8, 12, and 18 |
| Change from baseline in Caregiver Activity Survey (CAS) | Screening and Weeks 1, 8, 12, and 18 |
| Change from baseline in laboratory tests | Screening and weekly from Weeks 1-18 |
| Change from baseline in electrocardiogram | Screening and Weeks 1, 8, 12, and 18 |
| Change from baseline in movement disorder rating scales, including Barnes Akathisia Rating Scale, Abnormal Involuntary Movement Scale, and Simpson-Angus Scale | Baseline and Weeks 1, 8, 12, and 18 |
| Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scores | Baseline and weekly from Weeks 1-18 |
| Change from baseline to endpoint in Patient Preference Scale (PPS) scores | Screening and Weeks 1, 8, 12, and 18 |
| Bassano del Grappa |
| Vicenza |
| 36061 |
| Italy |
| Pfizer Investigational Site | Bari | 70124 | Italy |
| Pfizer Investigational Site | Brescia | 25100 | Italy |
| Pfizer Investigational Site | Cagliari | 09045 | Italy |
| Pfizer Investigational Site | Cagliari | 09124 | Italy |
| Pfizer Investigational Site | Catania | 95123 | Italy |
| Pfizer Investigational Site | Florence | 50134 | Italy |
| Pfizer Investigational Site | Guardiagrele (CH) | 66016 | Italy |
| Pfizer Investigational Site | Messina | 98100 | Italy |
| Pfizer Investigational Site | Montichiari (brescia) | 25018 | Italy |
| Pfizer Investigational Site | Naples | 80131 | Italy |
| Pfizer Investigational Site | Parma | 43100 | Italy |
| Pfizer Investigational Site | Reggio Calabria | 89100 | Italy |
| Pfizer Investigational Site | Roma | 00135 | Italy |
| Pfizer Investigational Site | Roma | 00137 | Italy |
| Pfizer Investigational Site | Sassari | 07100 | Italy |
| Pfizer Investigational Site | Siena | 53100 | Italy |
| Pfizer Investigational Site | Torino | 10126 | Italy |
| Pfizer Investigational Site | Trieste | 34126 | Italy |
| Pfizer Investigational Site | Verona | 37126 | Italy |
| Pfizer Investigational Site |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003024 | Clozapine |
| C092292 | ziprasidone |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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