Phase 3 N=162 Treatment

Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)

Bipolar Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00265330 ↗

Enrolled (actual)

162

Serious AEs

10.5%

Results posted

Apr 2009

Primary outcome: Primary: Young Mania Rating Scale (YMRS) Total Score Change From Baseline — -3.8; -4.0; -6.3; -6.1 score on scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ziprasidone oral capsules (Drug)
Age: Pediatric · 10+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Young Mania Rating Scale (YMRS) Total Score Change From Baseline	-3.8; -4.0; -6.3; -6.1; 1.5; -3.3	—
PRIMARY Clinical Global Impression of Severity (CGI-S) Change From Baseline	-0.2; -0.5; -0.4; -0.7; -0.7; -0.7	—
PRIMARY Incidence of Lab Abnormalities	44; 34; 32; 22; 13; 13	—
PRIMARY Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol	-7.5; -8.9; -7.6; -7.7; -10.3; -8.6	—
PRIMARY Change in Hormones	0.9; -23.4; -0.4; 2.7; 1.9; 1.0	—
PRIMARY Mean Change From Baseline in Supine Systolic Blood Pressure	0.4; 1.1; 1.2; 1.2; 1.4; -0.7	—
PRIMARY Mean Change From Baseline in Supine Diastolic Blood Pressure	-0.5; 0.5; 0.6; 0.5; -0.4; -2.4	—
PRIMARY Mean Change From Baseline in Supine Pulse Rates	1.4; 2.0; -1.8; 1.0; 1.4; -3.0	—
PRIMARY Mean Change From Baseline in Standing Systolic Blood Pressure	1.4; 3.7; 1.6; 2.0; 2.4; 0.5	—
PRIMARY Mean Change From Baseline in Standing Diastolic Blood Pressure	0.7; 2.0; 1.4; 1.2; 1.6; -0.1	—
PRIMARY Mean Change From Baseline in Standing Pulse Rates	3.5; 2.9; 0.3; 3.8; 2.6; 0.5	—
PRIMARY Mean Change From Baseline for Body Weight	1.3; 3.9; 1.4	—
PRIMARY Mean Change From Baseline for Body Mass Index (BMI) Z-Score	0.0; 0.1; 0.0	—
PRIMARY Body Mass Index (BMI) Z-score Frequency	0; 0; 0; 1; 27; 39	—
PRIMARY Body Mass Index (BMI) Z-score Frequency	0; 0; 0; 1; 27; 39	—
PRIMARY Mean Change From Baseline for QTcF Intervals	4.8; 3.5; 7.6; 7.0; 4.3; 6.2	—
PRIMARY Frequency of Largest Categorical Increases in QTcF for Males	0; 0; 0; 28; 0	—
PRIMARY Frequency of Largest Categorical Increases in QTcF for Females	3; 0; 0; 10; 2	—
PRIMARY Frequency of Largest Categorical Increases in QTcF - All Subjects	3; 0; 0; 38; 2	—

Summary

The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed)

Eligibility Criteria

Inclusion Criteria

Participation in double-blind treatment study A1281132, meeting specific criteria of duration and safety

Exclusion Criteria

Imminent risk of suicide or homicide, as judged by the site investigator;serious adverse event related to study medication in study A1281132; significant prolongation of QT interval in study A1281132.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00265330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.