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)

Young Mania Rating Scale (YMRS) Total Score Change From Baseline

时间窗: 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

时间窗: 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

时间窗: Week 6, Week 26

Mean Change: lab value at observation minus lab value at baseline.

Change in Hormones

时间窗: Week 6, Week 26

Mean Change: lab value at observation minus lab value at baseline

Mean Change From Baseline in Supine Systolic Blood Pressure

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Week 6, Week 26

Mean change; body weight value at observation minus body weight value at baseline.

Body Mass Index (BMI) Z-score Frequency

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.