Adjunctive Ziprasidone in the Treatment of Bipolar I Depression
NCT ID: NCT00483548
Last Updated: 2021-03-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
298 participants
INTERVENTIONAL
2007-10-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ziprasidone
Active treatment, double-blind, randomized treatment arm
Ziprasidone
Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to 40 mg/day can occur after subject has received previous lower dose for at least 1 day.
Placebo
Inactive, placebo treatment, double-blind, randomized arm
Placebo
Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm
Interventions
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Ziprasidone
Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to 40 mg/day can occur after subject has received previous lower dose for at least 1 day.
Placebo
Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Significant heart disease including abnormalities in the heart's rhythm (QT prolongation)
* Psychotic symptoms (hallucinations and/or delusions).
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Chandler, Arizona, United States
Pfizer Investigational Site
Litchfield Park, Arizona, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
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Little Rock, Arkansas, United States
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Springdale, Arkansas, United States
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Costa Mesa, California, United States
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Oceanside, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Boca Raton, Florida, United States
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Boca Raton, Florida, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Sanford, Florida, United States
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St. Petersburg, Florida, United States
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West Palm Beach, Florida, United States
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Chicago, Illinois, United States
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Skokie, Illinois, United States
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Greenwood, Indiana, United States
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Indianapolis, Indiana, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Lake Charles, Louisiana, United States
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Rockville, Maryland, United States
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Boston, Massachusetts, United States
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Watertown, Massachusetts, United States
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Clinton Township, Michigan, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Nashua, New Hampshire, United States
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Cherry Hill, New Jersey, United States
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Clementon, New Jersey, United States
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Brooklyn, New York, United States
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Glen Oaks, New York, United States
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New York, New York, United States
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Olean, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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Chapel Hill, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Lake Jackson, Texas, United States
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Charlottesville, Virginia, United States
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Kirkland, Washington, United States
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Richland, Washington, United States
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Seattle, Washington, United States
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Brown Deer, Wisconsin, United States
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Westmead, New South Wales, Australia
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Everton Park, Queensland, Australia
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Spring Hill, Queensland, Australia
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Richmond, Victoria, Australia
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Ellisbridge, Ahmedabad, India
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Ahmedabad, Gujarat, India
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Aurangabad, Maharashtra, India
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Pune, Maharashtra, India
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Pune, Maharashtra, India
Pfizer Investigational Site
Delhi, New Delhi, India
Countries
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References
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Sachs GS, Ice KS, Chappell PB, Schwartz JH, Gurtovaya O, Vanderburg DG, Kasuba B. Efficacy and safety of adjunctive oral ziprasidone for acute treatment of depression in patients with bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Oct;72(10):1413-22. doi: 10.4088/JCP.09m05934.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A1281158
Identifier Type: -
Identifier Source: org_study_id
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