3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects
NCT ID: NCT00312494
Last Updated: 2021-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
680 participants
INTERVENTIONAL
2006-04-30
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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Placebo
Placebo
Placebo with mood stabilizer (either lithium or divalproex)
Ziprasidone 20-40mg twice a day (BID)
Ziprasidone
Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex)
Ziprasidone 60-80mg BID
Ziprasidone
Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)
Interventions
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Placebo
Placebo with mood stabilizer (either lithium or divalproex)
Ziprasidone
Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex)
Ziprasidone
Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At screening and at baseline (within 12 hours prior to the first dose of double-blind medication) subjects must have a Young Mania Rating Scale score of 18 or higher.
* Subjects must be actively receiving lithium or divalproex for their bipolar disorder in order to be considered for this study.
Exclusion Criteria
* Subjects with other DSM-IV-TR Axis I or Axis II disorders (in addition to Bipolar I disorder) are ineligible if the comorbid condition is clinically unstable, requires treatment, or has been a primary focus of treatment within the 6-month period prior to screening.
18 Years
65 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
Dothan, Alabama, United States
Pfizer Investigational Site
Scottsdale, Arizona, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
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Cerritos, California, United States
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Costa Mesa, California, United States
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Escondido, California, United States
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Glendale, California, United States
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Huntington Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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National City, California, United States
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Oceanside, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Hartford, Connecticut, United States
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New Britain, Connecticut, United States
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DeLand, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Lauderhill, Florida, United States
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North Miami, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Des Plaines, Illinois, United States
Pfizer Investigational Site
Hoffman Estates, Illinois, United States
Pfizer Investigational Site
Hoffman Estates, Illinois, United States
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Schaumburg, Illinois, United States
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Greenwood, Indiana, United States
Pfizer Investigational Site
Prairie Village, Kansas, United States
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Glen Burnie, Maryland, United States
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Flowood, Mississippi, United States
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Kansas City, Missouri, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Clementon, New Jersey, United States
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Princeton, New Jersey, United States
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Amityville, New York, United States
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Buffalo, New York, United States
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Cedarhurst, New York, United States
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Elmsford, New York, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Dallas, Texas, United States
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Irving, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
Pfizer Investigational Site
Kirkland, Washington, United States
Countries
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References
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Sachs GS, Vanderburg DG, Edman S, Karayal ON, Kolluri S, Bachinsky M, Cavus I. Adjunctive oral ziprasidone in patients with acute mania treated with lithium or divalproex, part 2: influence of protocol-specific eligibility criteria on signal detection. J Clin Psychiatry. 2012 Nov;73(11):1420-5. doi: 10.4088/JCP.11m07389.
Sachs GS, Vanderburg DG, Karayal ON, Kolluri S, Bachinsky M, Cavus I. Adjunctive oral ziprasidone in patients with acute mania treated with lithium or divalproex, part 1: results of a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2012 Nov;73(11):1412-9. doi: 10.4088/JCP.11m07388.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A1281143
Identifier Type: -
Identifier Source: org_study_id
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