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Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Scottsdale, Arizona, 85251 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
10-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years

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

- Imminent risk of suicide or homicide, as judged by the site investigator; any history
of serious or unstable medical illness, including risk for QT prolongation

NCT00257166
Pfizer
Completed
Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)

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Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
Four Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Ziprasidone oral capsules
    Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.
  • Drug: placebo oral capsules
    Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.
  • Experimental: Ziprasidone oral capsules
    Intervention: Drug: Ziprasidone oral capsules
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo oral capsules
Findling RL, Cavu? I, Pappadopulos E, Vanderburg DG, Schwartz JH, Gundapaneni BK, DelBello MP. Efficacy, long-term safety, and tolerability of ziprasidone in children and adolescents with bipolar disorder. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):545-57. doi: 10.1089/cap.2012.0029. Epub 2013 Oct 10.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
238
July 2007
July 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years

Exclusion Criteria:

  • Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for QT prolongation
Sexes Eligible for Study: All
10 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00257166
A1281132
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2013

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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