A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Low-Dose Ziprasidone
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Drug: Ziprasidone
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.
Other Names:
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Active Comparator: High-Dose Ziprasidone
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Drug: Ziprasidone
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children and teens with Bipolar I Disorder (manic or mixed), schizophrenia or schizoaffective disorder
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Willingness to discontinue all antipsychotic medications during the study period
Exclusion Criteria:
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Patients who are clinically stable on treatments that are well tolerated
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Substance-induced psychotic disorders
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Pfizer Investigational Site | San Diego | California | United States | 92111 |
2 | Pfizer Investigational Site | Altamonte Springs | Florida | United States | 32701 |
3 | Pfizer Investigational Site | Libertyville | Illinois | United States | 60048 |
4 | Pfizer Investigational Site | Lexington | Kentucky | United States | 40509 |
5 | Pfizer Investigational Site | Belmont | Massachusetts | United States | 02478 |
6 | Pfizer Investigational Site | Brighton | Massachusetts | United States | 02135 |
7 | Pfizer Investigational Site | Las Vegas | Nevada | United States | 89103 |
8 | Pfizer Investigational Site | Las Vegas | Nevada | United States | 89117 |
9 | Pfizer Investigational Site | Las Vegas | Nevada | United States | 89128 |
10 | Pfizer Investigational Site | Turnersville | New Jersey | United States | 08012 |
11 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45224 |
12 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45229 |
13 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45267-0559 |
14 | Pfizer Investigational Site | Cleveland | Ohio | United States | 44106 |
15 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19104-3309 |
16 | Pfizer Investigational Site | Kirkland | Washington | United States | 98033 |
17 | Pfizer Investigational Site | Kirkland | Washington | United States | 98034 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A1281123