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Please see Detailed Description for termination reason.
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The purpose of this study is to evaluate the efficacy and safety of ziprasidone in acute exacerbation of schizophrenia or schizoaffective disorder, including patients with recent onset of symptoms
The study was prematurely discontinued due to the difficulty of subject recruitment on March 24, 2005. There were no safety concerns that led to the decision to terminate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziprasidone | Drug | Ziprasidone 20 mg capsules twice daily on Days 1-3; dose could be increased if clinically indicated up to 80 mg twice daily; total treatment duration was to be 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24 | Week 24 | |
| Change from baseline in PANSS (Depression-C) score at Week 24 | Week 24 | |
| Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24 | Week 24 | |
| Change from baseline in CGI-S total score at Week 24 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs and weight at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 | Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 | |
| Change from baseline in Clinical Global Impressions-Improvement (CGI-I) score at Week 24 |
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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 | Lisbon | 1600-219 | Portugal |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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|
| Week 24 |
| Adverse events on Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 | Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 |
| Change from baseline in Global Assessment of Functioning (GAF) score at Week 24 | Week 24 |
| Laboratory parameters at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 | Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 |
| Simpson-Angus Scale (SAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 | Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 |
| Barnes Akathisia Scale (BAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 | Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 |
| Electrocardiogram | Screening and Month 4 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
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