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

Phase 3

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Ziprasidone oral capsules

• Registration Number: NCT00265330
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-12-12
• Study First Submitted QC: 2005-12-12
• Study First Posted: 2005-12-14
• Study Start: 2006-03
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-01-22
• Results First Submitted QC: 2009-03-02
• Results First Posted: 2009-04-03
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open	Ziprasidone oral capsules	-

Primary Outcome Measures

Name	Time	Method
Young Mania Rating Scale (YMRS) Total Score Change From Baseline	baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)	YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132.
Incidence of Lab Abnormalities	Week 26	number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality.
Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol	Week 6, Week 26	Mean Change: lab value at observation minus lab value at baseline.
Change in Hormones	Week 6, Week 26	Mean Change: lab value at observation minus lab value at baseline
Mean Change From Baseline in Supine Systolic Blood Pressure	Week 1 through Week 26	Mean Change: vital sign value at observation minus vital sign value at baseline
Clinical Global Impression of Severity (CGI-S) Change From Baseline	baseline and 26 Weeks; 26 Weeks LOCF	CGI-S Scale:standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Change: score at observation minus score at baseline. Score: 1 (not ill at all) to 7 (among most extremely ill). Baseline = last available observation from parent double-blind study(A1281132).
Mean Change From Baseline in Supine Diastolic Blood Pressure	Week 1 through Week 26	Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline in Supine Pulse Rates	Week 1 through Week 26	Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline in Standing Diastolic Blood Pressure	Week 1 through Week 26	Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline for Body Weight	Week 6, Week 26	Mean change; body weight value at observation minus body weight value at baseline.
Body Mass Index (BMI) Z-score Frequency	Week 26	change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
Mean Change From Baseline for QTcF Intervals	Baseline to Week 26 (end of study)	QT intervals (observed in an electrocardiogram)corrected using Fridericia's formula (QTcF). Mean change: mean change of observation minus baseline. Baseline: last available observation in the parent double-blind study.
Mean Change From Baseline in Standing Systolic Blood Pressure	Week 1 through Week 26	Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline in Standing Pulse Rates	Week 1 through Week 26	Mean Change: vital sign value at observation minus vital sign value at baseline
Frequency of Largest Categorical Increases in QTcF for Males	Week 26 (end of study)	QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
Frequency of Largest Categorical Increases in QTcF - All Subjects	Week 26 (end of study)	QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
Mean Change From Baseline for Body Mass Index (BMI) Z-Score	Week 6, 26, early termination	mean change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
Frequency of Largest Categorical Increases in QTcF for Females	Week 26 (end of study)	QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 West Allis, Wisconsin, United States