Bipolar Disorder, Schizoaffective Disorder, Schizophrenia
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders
Interventions
DRUGZiprasidone
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.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Children and teens with Bipolar I Disorder (manic or mixed), schizophrenia or schizoaffective disorder * Willingness to discontinue all antipsychotic medications during the study period
Exclusion criteria
* Patients who are clinically stable on treatments that are well tolerated * Substance-induced psychotic disorders
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 movement disorder rating scale scores at Weeks 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 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 |
Countries
United States
Outcome results
None listed