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The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Dose Ziprasidone | Active Comparator |
| |
| High-Dose Ziprasidone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziprasidone | Drug | Period 1: Initial dose of oral ziprasidone suspension 20 mg twice daily, which was titrated up in 20 mg twice daily increments to a maximum dose of 80 mg twice daily by Day 10. Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events at Baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27. | 27 weeks | |
| Electrocardiograms and vital signs at Screening, baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27. | 27 weeks | |
| Laboratory data at Screening and Weeks 3, 12, and 27. | 27 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impressions-Improvement (CGI-I) scale scores on Day 4 and at Weeks 1, 2, and 3. | 3 weeks | |
| Mean change from baseline in Childrens' Global Assessment Scale (CGAS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27. | 27 weeks |
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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 | San Diego | California | 92111 | United States | ||
| 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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| Ziprasidone | Drug | Period 1: Initial dose of oral ziprasidone suspension 10 mg twice daily, which was titrated up in 10 mg twice daily increments to a maximum dose of 40 mg twice daily by Day 10. Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1. |
|
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| Serum concentrations of ziprasidone and its major metabolites at Weeks 1, 3, 12, and 27. | 27 weeks |
| Mean change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores on Day 4 and at Weeks 1, 2, 3, 12, and 27. | 27 weeks |
| Mean change from baseline in Young Mania Rating Scale (YMRS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27. | 27 weeks |
| Mean change from baseline in Brief Psychiatric Rating Scale-Anchored (BPRS-A) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27. | 27 weeks |
| Mean change from baseline in movement disorder rating scale scores at Weeks 3, 12, and 27. | 27 weeks |
| Altamonte Springs |
| Florida |
| 32701 |
| United States |
| Pfizer Investigational Site | Libertyville | Illinois | 60048 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40509 | United States |
| Pfizer Investigational Site | Belmont | Massachusetts | 02478 | United States |
| Pfizer Investigational Site | Brighton | Massachusetts | 02135 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89103 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89117 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89128 | United States |
| Pfizer Investigational Site | Turnersville | New Jersey | 08012 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45224 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45229 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45267-0559 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44106 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19104-3309 | United States |
| Pfizer Investigational Site | Kirkland | Washington | 98033 | United States |
| Pfizer Investigational Site | Kirkland | Washington | 98034 | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
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