Status:
COMPLETED
Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Bipolar Disorder
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief 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).
Eligibility Criteria
Inclusion
- DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT00257166
Start Date
January 1 2006
End Date
July 1 2007
Last Update
March 3 2021
Active Locations (50)
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1
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85251
2
Pfizer Investigational Site
Orange, California, United States, 92868
3
Pfizer Investigational Site
San Diego, California, United States, 92123
4
Pfizer Investigational Site
Denver, Colorado, United States, 80218