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

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Dotham, Alabama, 36303 United States
Contact
1-800-718-1021
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.
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- 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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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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