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This study was conducted to examine the efficacy and tolerability of ziprasidone intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin American population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziprasidone | Drug | IM ziprasidone at an initial dose of 10 or 20 mg for the first 3 days; additional doses could be administered according to clinical need, with the maximum total daily IM dose of 40 mg. On Day 4, IM treatment was switched to oral (PO) treatment at an initial dose of 40 mg twice daily for the first 2 days; doses could be subsequently adjusted within the range of 40 to 80 mg twice daily. Total treatment duration was 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to endpoint in Brief Psychiatric Rating Scale (BPRS) total score | Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale score | Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) | |
| Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scale score |
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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 | Monterrey | Nuevo León | 64800 | Mexico | ||
| 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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|
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| Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) |
| Simpson-Angus Scale (SAS) | Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO) |
| Barnes Akathisia Scale (BAS) | Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO) |
| Laboratory tests | Screening and Week 6 |
| Electrocardiogram | Screening and Week 6 |
| Adverse events | Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) |
| Abnormal Involuntary Movement Scale (AIMS) | Day 1 (IM), Day 4 (Switch), and Week 6 (PO) |
| Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total score | Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) |
| Change from baseline to endpoint in Covi Anxiety Scale score | Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) |
| Change from baseline to endpoint in Positive PANSS subscale score | Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) |
| Change from baseline to endpoint in Negative PANSS subscale score | Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) |
| DF |
| 14420 |
| Mexico |
| Pfizer Investigational Site | Mexico City | 14050 | Mexico |
| Pfizer Investigational Site | Mexico D F | 14269 | Mexico |
| 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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