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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: Ziprasidone oral capsules (Drug); placebo oral capsules (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).

Clinical Details

Official title: Four Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4

Secondary outcome:

Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3

Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4

Clinical Global Impression - Improvement (CGI-I) Score

Eligibility

Minimum age: 10 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years

Exclusion Criteria:

- Imminent risk of suicide or homicide, as judged by the site investigator; any history

of serious or unstable medical illness, including risk for QT prolongation

Locations and Contacts

Pfizer Investigational Site, Scottsdale, Arizona 85251, United States

Pfizer Investigational Site, Orange, California 92868, United States

Pfizer Investigational Site, San Diego, California 92123, United States

Pfizer Investigational Site, Denver, Colorado 80218, United States

Pfizer Investigational Site, Altamonte Springs, Florida 32701, United States

Pfizer Investigational Site, Ft. Lauderdale, Florida 33301, United States

Pfizer Investigational Site, North Miami, Florida 33161, United States

Pfizer Investigational Site, Orange City, Florida 32763, United States

Pfizer Investigational Site, Tavares, Florida 32778, United States

Pfizer Investigational Site, Decatur, Georgia 30033, United States

Pfizer Investigational Site, Honolulu, Hawaii 96826, United States

Pfizer Investigational Site, Des Plaines, Illinois 60016, United States

Pfizer Investigational Site, Schaumburg, Illinois 60194, United States

Pfizer Investigational Site, Terre Haute, Indiana 47802, United States

Pfizer Investigational Site, Lexington, Kentucky 40509, United States

Pfizer Investigational Site, Owensboro, Kentucky 42301, United States

Pfizer Investigational Site, Baton Rouge, Louisiana 70809, United States

Pfizer Investigational Site, Shreveport, Louisiana 71103, United States

Pfizer Investigational Site, Pikesville, Maryland 21208, United States

Pfizer Investigational Site, Towson, Maryland 21204, United States

Pfizer Investigational Site, Towson, Maryland 21286, United States

Pfizer Investigational Site, Clinton Township, Michigan 48038, United States

Pfizer Investigational Site, Meridian, Mississippi 39301, United States

Pfizer Investigational Site, St. Louis, Missouri 63044-2588, United States

Pfizer Investigational Site, Lincoln, Nebraska 68510, United States

Pfizer Investigational Site, Omaha, Nebraska 68131, United States

Pfizer Investigational Site, Albuquerque, New Mexico 87102, United States

Pfizer Investigational Site, Buffalo, New York 14215, United States

Pfizer Investigational Site, Rochester, New York 14618, United States

Pfizer Investigational Site, Cincinnati, Ohio 45267-0559, United States

Pfizer Investigational Site, Cincinnati, Ohio 45229, United States

Pfizer Investigational Site, Cincinnati, Ohio 45224, United States

Pfizer Investigational Site, Cleveland, Ohio 44106-5080, United States

Pfizer Investigational Site, Columbus, Ohio 43210, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma 73101, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma 73107, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma 73112, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma 73116, United States

Pfizer Investigational Site, Tulsa, Oklahoma 74114, United States

Pfizer Investigational Site, Charleston, South Carolina 29405, United States

Pfizer Investigational Site, Arlington, Texas 76011, United States

Pfizer Investigational Site, DeSoto, Texas 75115, United States

Pfizer Investigational Site, Fort Worth, Texas 76102, United States

Pfizer Investigational Site, Lake Jackson, Texas 77566, United States

Pfizer Investigational Site, Plano, Texas 75093, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, Kirkland, Washington 98033, United States

Pfizer Investigational Site, Spokane, Washington 99204, United States

Pfizer Investigational Site, Milwaukee, Wisconsin 53226, United States

Pfizer Investigational Site, West Allis, Wisconsin 53227, United States

Additional Information

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

Starting date: January 2006
Last updated: July 24, 2013

Page last updated: August 20, 2015

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