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

Study Overview
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Brief Summary
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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)

Official Title
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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)

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Ziprasidone oral capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open<br> | Drug: Ziprasidone oral capsules<br>* Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Young Mania Rating Scale (YMRS) Total Score Change From Baseline | 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. | baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF) | 
| Clinical Global Impression of Severity (CGI-S) Change From Baseline | 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). | baseline and 26 Weeks; 26 Weeks LOCF | 
| Incidence of Lab Abnormalities | number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality. | Week 26 | 
| Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol | Mean Change: lab value at observation minus lab value at baseline. | Week 6, Week 26 | 
| Change in Hormones | Mean Change: lab value at observation minus lab value at baseline | Week 6, Week 26 | 
| Mean Change From Baseline in Supine Systolic Blood Pressure | Mean Change: vital sign value at observation minus vital sign value at baseline | Week 1 through Week 26 | 
| Mean Change From Baseline in Supine Diastolic Blood Pressure | Mean Change: vital sign value at observation minus vital sign value at baseline | Week 1 through Week 26 | 
| Mean Change From Baseline in Supine Pulse Rates | Mean Change: vital sign value at observation minus vital sign value at baseline | Week 1 through Week 26 | 
| Mean Change From Baseline in Standing Systolic Blood Pressure | Mean Change: vital sign value at observation minus vital sign value at baseline | Week 1 through Week 26 | 
| Mean Change From Baseline in Standing Diastolic Blood Pressure | Mean Change: vital sign value at observation minus vital sign value at baseline | Week 1 through Week 26 | 
| Mean Change From Baseline in Standing Pulse Rates | Mean Change: vital sign value at observation minus vital sign value at baseline | Week 1 through Week 26 | 
| Mean Change From Baseline for Body Weight | Mean change; body weight value at observation minus body weight value at baseline. | Week 6, Week 26 | 
| Mean Change From Baseline for Body Mass Index (BMI) Z-Score | 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 | Week 6, 26, early termination | 
| Body Mass Index (BMI) Z-score Frequency | 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 | Week 6 | 
| Body Mass Index (BMI) Z-score Frequency | 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 | Week 26 | 
| Mean Change From Baseline for QTcF Intervals | 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. | Baseline to Week 26 (end of study) | 
| Frequency of Largest Categorical Increases in QTcF for Males | QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF. | Week 26 (end of study) | 
| Frequency of Largest Categorical Increases in QTcF for Females | QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF. | Week 26 (end of study) | 
| Frequency of Largest Categorical Increases in QTcF - All Subjects | QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF. | Week 26 (end of study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)