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

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

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).

Key facts

Study ID

NCT00257166

Run by

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

People needed

238

Starts

2006-01-01

Expected to finish

2007-07-01

Last updated by the study team

2021-03-03

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Scottsdale, Arizona, United States
• Pfizer Investigational Site — Orange, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Altamonte Springs, Florida, United States
• Pfizer Investigational Site — Fort Lauderdale, Florida, United States
• Pfizer Investigational Site — North Miami, Florida, United States
• Pfizer Investigational Site — Orange City, Florida, United States
• Pfizer Investigational Site — Tavares, Florida, United States
• Pfizer Investigational Site — Decatur, Georgia, United States
• Pfizer Investigational Site — Honolulu, Hawaii, United States
• Pfizer Investigational Site — Des Plaines, Illinois, United States
• Pfizer Investigational Site — Schaumburg, Illinois, United States
• Pfizer Investigational Site — Terre Haute, Indiana, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Owensboro, Kentucky, United States
• Pfizer Investigational Site — Baton Rouge, Louisiana, United States
• Pfizer Investigational Site — Shreveport, Louisiana, United States
• Pfizer Investigational Site — Pikesville, Maryland, United States
• Pfizer Investigational Site — Towson, Maryland, United States
• Pfizer Investigational Site — Towson, Maryland, United States
• Pfizer Investigational Site — Clinton Township, Michigan, United States
• Pfizer Investigational Site — Meridian, Mississippi, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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