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3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: Placebo (Drug); Ziprasidone (Drug); Ziprasidone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects

Clinical Details

Official title: A Three-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Add-On Oral Ziprasidone in Subjects With Acute Mania Treated With Lithium or Divalproex

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS)

Secondary outcome:

Change From Baseline to Week 1 and Week 2 in YMRS

Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores

Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score

Clinical Global Impression - Improvement (CGI-I) Scale Scores

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score

Change From Baseline in Global Assessment of Functioning (GAF) Score

Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score

Anonymized Pharmacogenomic Blood Draw

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode

manic (296. 4x), or mixed (296. 6x) as defined in Diagnostic and Statistical Manual of

Mental Disorders - Text Revision (DSM-IV TR) and determined by the Mini International

Neuropsychiatric Interview (MINI).

- 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 a Diagnostic and Statistical Manual of Mental Disorders IV- Text

Revision (DSM-IV TR) diagnosis of schizophrenia (295. XX), schizoaffective disorder (295. 70), schizophreniform disorder (295. 40), delusional disorder (297. 1), or psychotic disorder not otherwise specified (NOS) (298. 9).

- 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.

Locations and Contacts

Pfizer Investigational Site, Dotham, Alabama 36303, United States

Pfizer Investigational Site, Dothan, Alabama 36303, United States

Pfizer Investigational Site, Scottsdale, Arizona 85251, United States

Pfizer Investigational Site, Little Rock, Arkansas 72211, United States

Pfizer Investigational Site, Cerritos, California 90703, United States

Pfizer Investigational Site, Costa Mesa, California 92626, United States

Pfizer Investigational Site, Escondido, California 92025, United States

Pfizer Investigational Site, Glendale, California 91204, United States

Pfizer Investigational Site, Huntington Beach, California 92647, United States

Pfizer Investigational Site, Los Angeles, California 90057, United States

Pfizer Investigational Site, Los Angeles, California 90061, United States

Pfizer Investigational Site, National City, California 91950, United States

Pfizer Investigational Site, Oceanside, California 92056, United States

Pfizer Investigational Site, San Diego, California 92114, United States

Pfizer Investigational Site, San Diego, California 92120, United States

Pfizer Investigational Site, San Diego, California 92126, United States

Pfizer Investigational Site, Torrance, California 90505, United States

Pfizer Investigational Site, Hartford, Connecticut 06106, United States

Pfizer Investigational Site, New Britain, Connecticut 06050, United States

Pfizer Investigational Site, DeLand, Florida 32720, United States

Pfizer Investigational Site, Ft Lauderdale, Florida 33308, United States

Pfizer Investigational Site, Ft. Lauderdale, Florida 33301, United States

Pfizer Investigational Site, Gainesville, Florida 32607, United States

Pfizer Investigational Site, Hollywood, Florida 33021, United States

Pfizer Investigational Site, Jacksonville, Florida 32256-2006, United States

Pfizer Investigational Site, Lauderhill, Florida 33119, United States

Pfizer Investigational Site, North Miami, Florida 33161, United States

Pfizer Investigational Site, Atlanta, Georgia 30308, United States

Pfizer Investigational Site, Honolulu, Hawaii 96813, United States

Pfizer Investigational Site, Des Plaines, Illinois 60016, United States

Pfizer Investigational Site, Hoffman Estates, Illinois 60194, United States

Pfizer Investigational Site, Hoffman Estates, Illinois 60169, United States

Pfizer Investigational Site, Schaumburg, Illinois 60194, United States

Pfizer Investigational Site, Greenwood, Indiana 46143, United States

Pfizer Investigational Site, Prairie Village, Kansas 66206, United States

Pfizer Investigational Site, Glen Burnie, Maryland 21061, United States

Pfizer Investigational Site, Flowood, Mississippi 39232, United States

Pfizer Investigational Site, Kansas City, Missouri 64133, United States

Pfizer Investigational Site, St. Charles, Missouri 63304, United States

Pfizer Investigational Site, St. Louis, Missouri 63128, United States

Pfizer Investigational Site, St. Louis, Missouri 63118, United States

Pfizer Investigational Site, St. Louis, Missouri 63044-2588, United States

Pfizer Investigational Site, Las Vegas, Nevada 89102, United States

Pfizer Investigational Site, Las Vegas, Nevada 89103, United States

Pfizer Investigational Site, Clementon, New Jersey 08021, United States

Pfizer Investigational Site, Princeton, New Jersey 08540, United States

Pfizer Investigational Site, Amityville, New York 11701, United States

Pfizer Investigational Site, Buffalo, New York 14215, United States

Pfizer Investigational Site, Cedarhurst, New York 11516, United States

Pfizer Investigational Site, Elmsford, New York 10523, United States

Pfizer Investigational Site, Raleigh, North Carolina 27609, United States

Pfizer Investigational Site, Cincinnati, Ohio 45219, United States

Pfizer Investigational Site, Cincinnati, Ohio 45220, United States

Pfizer Investigational Site, Cincinnati, Ohio 45267-0559, United States

Pfizer Investigational Site, Cleveland, Ohio 44113, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma 73112, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19149, United States

Pfizer Investigational Site, Charleston, South Carolina 29405, United States

Pfizer Investigational Site, Dallas, Texas 75228, United States

Pfizer Investigational Site, Irving, Texas 75062, United States

Pfizer Investigational Site, Plano, Texas 75024, United States

Pfizer Investigational Site, San Antonio, Texas 78229-3900, United States

Pfizer Investigational Site, San Antonio, Texas 78259-3509, United States

Pfizer Investigational Site, Richmond, Virginia 23229, United States

Pfizer Investigational Site, Richmond, Virginia 23230, United States

Pfizer Investigational Site, Bellevue, Washington 98004, United States

Pfizer Investigational Site, Kirkland, Washington 98033, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: April 2006
Last updated: February 2, 2010

Page last updated: August 23, 2015

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