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

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)

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)

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder
• Intervention / Treatment: Drug: Ziprasidone oral capsules

• Study Type: Interventional
• Enrollment (Actual): 169
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Pfizer Investigational Site
  • California
    • San Diego, California, United States, 92123
      • Pfizer Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Pfizer Investigational Site
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Pfizer Investigational Site
    • Fort Lauderdale, Florida, United States, 33301
      • Pfizer Investigational Site
    • North Miami, Florida, United States, 33161
      • Pfizer Investigational Site
    • Orange City, Florida, United States, 32763
      • Pfizer Investigational Site
    • Tavares, Florida, United States, 32778
      • Pfizer Investigational Site
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Pfizer Investigational Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • Pfizer Investigational Site
  • Indiana
    • Terre Haute, Indiana, United States, 47802
      • Pfizer Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Pfizer Investigational Site
    • Owensboro, Kentucky, United States, 42301
      • Pfizer Investigational Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Pfizer Investigational Site
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Pfizer Investigational Site
  • Mississippi
    • Meridian, Mississippi, United States, 39301
      • Pfizer Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63044-2588
      • Pfizer Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Pfizer Investigational Site
    • Omaha, Nebraska, United States, 68131
      • Pfizer Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Pfizer Investigational Site
  • New York
    • Rochester, New York, United States, 14618
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0559
      • Pfizer Investigational Site
    • Cincinnati, Ohio, United States, 45229
      • Pfizer Investigational Site
    • Cincinnati, Ohio, United States, 45224
      • Pfizer Investigational Site
    • Cleveland, Ohio, United States, 44106-5080
      • Pfizer Investigational Site
    • Columbus, Ohio, United States, 43210
      • Pfizer Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Pfizer Investigational Site
    • Oklahoma City, Oklahoma, United States, 73101
      • Pfizer Investigational Site
    • Oklahoma City, Oklahoma, United States, 73116
      • Pfizer Investigational Site
    • Oklahoma City, Oklahoma, United States, 73107
      • Pfizer Investigational Site
    • Tulsa, Oklahoma, United States, 74114
      • Pfizer Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29405
      • Pfizer Investigational Site
  • Texas
    • Arlington, Texas, United States, 76011
      • Pfizer Investigational Site
    • DeSoto, Texas, United States, 75115
      • Pfizer Investigational Site
    • Lake Jackson, Texas, United States, 77566
      • Pfizer Investigational Site
    • Plano, Texas, United States, 75093
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78229
      • Pfizer Investigational Site
  • Washington
    • Kirkland, Washington, United States, 98033
      • Pfizer Investigational Site
    • Spokane, Washington, United States, 99204
      • Pfizer Investigational Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Pfizer Investigational Site
    • West Allis, Wisconsin, United States, 53227
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Open	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 .

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (ACTUAL): January 1, 2008
• Study Completion (ACTUAL): January 1, 2008

Study Registration Dates

• First Submitted: December 12, 2005
• First Submitted That Met QC Criteria: December 12, 2005
• First Posted (ESTIMATE): December 14, 2005

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Disease; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Ziprasidone
• Other Study ID Numbers: A1281133