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

Bipolar Disorder Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265330
• Other study ID #: A1281133
• Status: Completed
• Phase: Phase 3
• Start date: March 2006
• Est. completion date: January 2008

Study information

• Verified date: March 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Drug:
• Ziprasidone oral capsules
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 .

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Altamonte Springs	Florida
United States	Pfizer Investigational Site	Arlington	Texas
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Clinton Township	Michigan
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	DeSoto	Texas
United States	Pfizer Investigational Site	Fort Lauderdale	Florida
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Kirkland	Washington
United States	Pfizer Investigational Site	Lake Jackson	Texas
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Meridian	Mississippi
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	North Miami	Florida
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Orange City	Florida
United States	Pfizer Investigational Site	Owensboro	Kentucky
United States	Pfizer Investigational Site	Plano	Texas
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Saint Louis	Missouri
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Scottsdale	Arizona
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Tavares	Florida
United States	Pfizer Investigational Site	Terre Haute	Indiana
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	West Allis	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	Incidence of Lab Abnormalities	number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality.	Week 26
Primary	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
Primary	Change in Hormones	Mean Change: lab value at observation minus lab value at baseline	Week 6, Week 26
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Mean Change From Baseline for Body Weight	Mean change; body weight value at observation minus body weight value at baseline.	Week 6, Week 26
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)

External Links

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