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A Phase 3, Randomized, 6-Month, Double-Blind Trial in Subjects With Bipolar I Disorder to Evaluate the Continued Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer (vs Placebo Plus a Mood Stabilizer) Following a Minimum of 2 Months of Response to Open-Label Treatment With Both Agents
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) after they have achieved 8 consecutive weeks of symptom improvement on the regimen.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Scottsdale, Arizona, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Costa Mesa, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
National City, California, United States
Pfizer Investigational Site
Sacramento, California, United States
Pfizer Investigational Site
San Diego, California, United States
Start Date
December 1, 2005
Primary Completion Date
May 1, 2008
Completion Date
May 1, 2008
Last Updated
March 25, 2021
584
ACTUAL participants
Placebo
DRUG
Ziprasidone Oral Capsule
DRUG
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
NCT04480918
NCT07140913
Data Source & Attribution
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