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

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NCT00312494

Last updated on October 5, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Dotham, Alabama, 36303 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00312494
Pfizer
Completed
3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects

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3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects
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
3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Placebo
    Placebo with mood stabilizer (either lithium or divalproex)
  • Drug: Ziprasidone
    Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex)
    Other Name: Geodon, Zeldox
  • Drug: Ziprasidone
    Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)
    Other Name: Geodon, Zeldox
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Ziprasidone 20-40mg twice a day (BID)
    Intervention: Drug: Ziprasidone
  • Experimental: Ziprasidone 60-80mg BID
    Intervention: Drug: Ziprasidone


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
680
December 2008
December 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00312494
A1281143
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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