Not Signed In -
Cefaclor capsules |
Ceclor |
Clinical Trial: Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
This study is not yet open for patient recruitment.
Verified by Pfizer November 2005
|
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Bipolar Disorder | Drug: Ziprasidone oral capsules | Phase III |
MedlinePlus related topics: Bipolar Disorder
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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)
Further study details as provided by Pfizer:
Primary Outcomes: Young Mania Rating Scale
Secondary Outcomes: Clinical Global Impression scale
Expected Total Enrollment: 222
Secondary Outcomes: Clinical Global Impression scale
Expected Total Enrollment: 222
Study start: December 2005
Eligibility
Ages Eligible for Study: 10 Years - 17 Years, Genders Eligible for Study: Both
Criteria
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00257166
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A1281132
Last Updated: December 8, 2005
Record first received: November 21, 2005
ClinicalTrials.gov Identifier: NCT00257166
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 8, 2005
Record first received: November 21, 2005
ClinicalTrials.gov Identifier: NCT00257166
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
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