A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders

Phase 2

Completed

• Conditions: Bipolar Disorder; Schizoaffective Disorder; Schizophrenia
• Interventions: Drug: Ziprasidone

• Registration Number: NCT00650611
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study Completion: 2005-03
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-Dose Ziprasidone	Ziprasidone	-
Low-Dose Ziprasidone	Ziprasidone	-

Primary Outcome Measures

Name	Time	Method
Laboratory data at Screening and Weeks 3, 12, and 27.	27 weeks
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

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impressions-Improvement (CGI-I) scale scores on Day 4 and at Weeks 1, 2, and 3.	3 weeks
Serum concentrations of ziprasidone and its major metabolites at Weeks 1, 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
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 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 movement disorder rating scale scores at Weeks 3, 12, and 27.	27 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Kirkland, Washington, United States