26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Overview
- Phase
- Phase 3
- Intervention
- Ziprasidone oral capsules
- Conditions
- Bipolar Disorder
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Enrollment
- 169
- Locations
- 1
- Primary Endpoint
- Young Mania Rating Scale (YMRS) Total Score Change From Baseline
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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)
Investigators
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.
Arms & Interventions
Open
Intervention: Ziprasidone oral capsules
Outcomes
Primary Outcomes
Young Mania Rating Scale (YMRS) Total Score Change From Baseline
Time Frame: 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
Time Frame: 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
Time Frame: Week 6, Week 26
Mean Change: lab value at observation minus lab value at baseline.
Change in Hormones
Time Frame: Week 6, Week 26
Mean Change: lab value at observation minus lab value at baseline
Mean Change From Baseline in Supine Systolic Blood Pressure
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Week 6, Week 26
Mean change; body weight value at observation minus body weight value at baseline.
Body Mass Index (BMI) Z-score Frequency
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.