3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects
NCT00312494
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Stanford, California
- DuBois, Pennsylvania
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Dallas, Texas
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | 3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects | |||
Official Title ICMJE | 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 | |||
Brief Summary | 3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Bipolar Disorder | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 680 | |||
Original Enrollment ICMJE | 405 | |||
Actual Study Completion Date ICMJE | December 2008 | |||
Actual Primary Completion Date | December 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00312494 | |||
Other Study ID Numbers ICMJE | A1281143 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |