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

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ziprasidone oral capsules
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open

Arm Description

Outcomes

Primary Outcome Measures

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.
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).
Incidence of Lab Abnormalities
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
Mean Change: lab value at observation minus lab value at baseline.
Change in Hormones
Mean Change: lab value at observation minus lab value at baseline
Mean Change From Baseline in Supine Systolic Blood Pressure
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline in Supine Diastolic Blood Pressure
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline in Supine Pulse Rates
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline in Standing Systolic Blood Pressure
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline in Standing Diastolic Blood Pressure
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline in Standing Pulse Rates
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline for Body Weight
Mean change; body weight value at observation minus body weight value at baseline.
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
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
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
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2005
Last Updated
March 2, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00265330
Brief Title
Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Pfizer Investigational Site
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33301
Country
United States
Facility Name
Pfizer Investigational Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Pfizer Investigational Site
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Pfizer Investigational Site
City
Tavares
State/Province
Florida
ZIP/Postal Code
32778
Country
United States
Facility Name
Pfizer Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Pfizer Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Pfizer Investigational Site
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Pfizer Investigational Site
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Pfizer Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Pfizer Investigational Site
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Pfizer Investigational Site
City
Meridian
State/Province
Mississippi
ZIP/Postal Code
39301
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63044-2588
Country
United States
Facility Name
Pfizer Investigational Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0559
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5080
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Pfizer Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73101
Country
United States
Facility Name
Pfizer Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73107
Country
United States
Facility Name
Pfizer Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Pfizer Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Pfizer Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Pfizer Investigational Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Pfizer Investigational Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Pfizer Investigational Site
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Pfizer Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pfizer Investigational Site
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Pfizer Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Pfizer Investigational Site
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24111980
Citation
Findling RL, Cavus I, Pappadopulos E, Vanderburg DG, Schwartz JH, Gundapaneni BK, DelBello MP. Efficacy, long-term safety, and tolerability of ziprasidone in children and adolescents with bipolar disorder. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):545-57. doi: 10.1089/cap.2012.0029. Epub 2013 Oct 10.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281133&StudyName=Safety%20and%20tolerability%20of%20ziprasidone%20in%20children%20and%20adolescents%20with%20bipolar%20I%20disorder%20%28manic%20or%20mixed%29
Description
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Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)

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