The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
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.
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.
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Altamonte Springs, Florida, United States
Adverse events at Baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27.
Time frame: 27 weeks
Electrocardiograms and vital signs at Screening, baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27.
Time frame: 27 weeks
Laboratory data at Screening and Weeks 3, 12, and 27.
Time frame: 27 weeks
Clinical Global Impressions-Improvement (CGI-I) scale scores on Day 4 and at Weeks 1, 2, and 3.
Time frame: 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.
Time frame: 27 weeks
Serum concentrations of ziprasidone and its major metabolites at Weeks 1, 3, 12, and 27.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 27 weeks
Mean change from baseline in movement disorder rating scale scores at Weeks 3, 12, and 27.
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Pfizer Investigational Site
Libertyville, Illinois, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Belmont, Massachusetts, United States
Pfizer Investigational Site
Brighton, Massachusetts, United States
Pfizer Investigational Site
Las Vegas, Nevada, United States
Pfizer Investigational Site
Las Vegas, Nevada, United States
Pfizer Investigational Site
Las Vegas, Nevada, United States
Pfizer Investigational Site
Turnersville, New Jersey, United States
...and 7 more locations
Time frame: 27 weeks