Status:
COMPLETED
Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Bipolar Mania
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or mixed symptoms) ...
Eligibility Criteria
Inclusion
- Adults meeting DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for Bipolar I Disorder (currently with manic or mixed symptoms)
Exclusion
- Ultra rapid cyclers and subjects with significant cardiovascular disease including history of QT prolongation and/or congenital long QT syndrome
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
584 Patients enrolled
Trial Details
Trial ID
NCT00280566
Start Date
December 1 2005
End Date
May 1 2008
Last Update
March 25 2021
Active Locations (107)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35226
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
3
Pfizer Investigational Site
Birmingham, Alabama, United States, 35924
4
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85251