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

Completed · Phase 3

Conditions studied: Bipolar Disorder

In brief

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)

Key facts

Study ID

NCT00265330

Run by

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

People needed

169

Starts

2006-03-01

Expected to finish

2008-01-01

Last updated by the study team

2021-03-25

Who can join

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

You may qualify if…

• Participation in double-blind treatment study A1281132, meeting specific criteria of duration and safety

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Scottsdale, Arizona, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Aurora, 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 — Terre Haute, Indiana, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Owensboro, Kentucky, United States
• Pfizer Investigational Site — Shreveport, Louisiana, 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
• Pfizer Investigational Site — Omaha, Nebraska, United States
• Pfizer Investigational Site — Albuquerque, New Mexico, United States
• Pfizer Investigational Site — Rochester, New York, 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

Full record on ClinicalTrials.gov

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