Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder



Status:Recruiting
Conditions:Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:10 - 17
Updated:3/28/2019
Start Date:May 23, 2014
End Date:October 5, 2020
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A PHASE 3, MULTICENTER, FOUR-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP EFFICACY AND SAFETY TRIAL OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (CURRENT OR MOST RECENT EPISODE MANIC)

The purpose of this study is to determine if ziprasidone is safe and effective for the
treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).


Inclusion Criteria:

- DSM V 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.
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707 North Broadway
Baltimore, Maryland 21205
443-923-9200
Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
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811 Juniper St NE
Atlanta, Georgia 30308
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2150 Peachford Road
Atlanta, Georgia 30338
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707 North Broadway
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1800 Orleans Street
Baltimore, Maryland 21287
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707 North Broadway
Baltimore, Maryland 21205
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1800 Orleans Street
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Boca Raton, Florida 33487
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Charlottesville, Virginia 22903
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Charlottesville, Virginia 22903
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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2068 Orange Tree Lane
Colton, California 92374
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281 W. Lane Ave
Columbus, Ohio 43210
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Dothan, Alabama 36303
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Everett, Washington 98201
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Garfield Heights, Ohio 44125
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75-59 263rd Street
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401 New Jersey 73
Marlton, New Jersey 08053
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