Status:
COMPLETED
3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
680 Patients enrolled
Trial Details
Trial ID
NCT00312494
Start Date
April 1 2006
End Date
December 1 2008
Last Update
March 29 2021
Active Locations (66)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Dothan, Alabama, United States, 36303
2
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85251
3
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72211
4
Pfizer Investigational Site
Cerritos, California, United States, 90703