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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Trial Summary
Trial Overview
Inclusion Criteria

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.
We found this trial at
52
sites
Johns Hopkins Hospital Pediatric Clinical Research Unit
Baltimore, Maryland 21231
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Kennedy Krieger Institute
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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California Pharmaceutical Research Institute, Inc
Anaheim, California 92804
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Anaheim, CA
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Atlanta Center for Medical Research
811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Atlanta, GA
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Atlanta Behavioral Research, LLC
2150 Peachford Road
Atlanta, Georgia 30338
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Atlanta, GA
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Hugo W. Moser Research Institute at Kennedy Krieger Institute Clinical Trials Unit
Baltimore, Maryland 21205
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Baltimore, MD
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Kennedy Krieger Institute Inpatient Clinic
707 North Broadway
Baltimore, Maryland 21205
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Baltimore, MD
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Charlotte R. Bloomberg Children's Center
1800 Orleans Street
Baltimore, Maryland 21287
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Baltimore, MD
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Kennedy Krieger Institute Outpatient Clinic
707 North Broadway
Baltimore, Maryland 21205
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Baltimore, MD
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Psychiatric Mental Health Program at Kennedy Krieger Institute Clinical Trials Unit
Baltimore, Maryland 21205
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Baltimore, MD
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Johns Hopkins Hospital Investigational Drug Services
1800 Orleans Street
Baltimore, Maryland 21287
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Baltimore, MD
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Da Vinci Research Institute Inc
Boca Raton, Florida 33487
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Boca Raton, FL
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Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
Buffalo, New York 14215
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Buffalo, NY
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UVA Child & Family Psychiatry Clinic
Charlottesville, Virginia 22903
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Charlottesville, VA
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Northridge Medical Plaza
1215 Lee Street
Charlottesville, Virginia 22903
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Charlottesville, VA
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University of Virginia Center for Psychopharmacology Research in Youth
Charlottesville, Virginia 22903
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Charlottesville, VA
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University of Cincinnati
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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Cincinnati, OH
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University Hospitals Case Medical Center Division of Child and Adolescent Psychiatry
Cleveland, Ohio 44106
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Cleveland, OH
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CMB Clinical Trials
2068 Orange Tree Lane
Colton, California 92374
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Colton, CA
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Ohio State University
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Harmonex Neuroscience Research
Dothan, Alabama 36303
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Dothan, AL
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Core Clinical Research
Everett, Washington 98201
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Everett, WA
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Eaastside Therapeutic dba Core Clinical Research
Everett, Washington 98201
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Everett, WA
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Eastside Therapeutic dba Core Clinical Research
Everett, Washington 98201
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Everett, WA
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Inova Clinical Trials and Research Centre
Fayetteville, Georgia 30214
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Fayetteville, GA
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Sarkis Clinical Trials
Gainesville, Florida 32607
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Gainesville, FL
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Rakesh Ranjan, MD & Associates Inc.
Garfield Heights, Ohio 44125
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Garfield Heights, OH
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The Zucker Hillside Hospital Northwell Health
75-59 263rd Street
Glen Oaks, New York 11004
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Glen Oaks, NY
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UT Health Science Center at Houston (UTHSC-H)
Houston, Texas 77054
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Houston, TX
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Woodland International Research Group, Inc.
Little Rock, Arkansas 72211
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Little Rock, AR
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Clinical Research Integrity(CRI) Lifetree, LLC
401 New Jersey 73
Marlton, New Jersey 08053
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Marlton, NJ
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PRA Health Sciences
Marlton, New Jersey 08053
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Marlton, NJ
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Manhattan Behavioral Medicine, LLC
New York, New York 10022
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New York, NY
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Sooner Clinical Research
Oklahoma City, Oklahoma 73112
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Oklahoma City, OK
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Cutting Edge Research Group
Oklahoma City, Oklahoma 73116
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Oklahoma City, OK
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Paradigm Research Professionals, Llc
Oklahoma City, Oklahoma 73112
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Oklahoma City, OK
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NRC Research Institute
Orange, California 92868
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Orange, CA
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Medical Research Group of Central Florida
Orange City, Florida 32763
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Orange City, FL
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APG Research, LLC
Orlando, Florida 32803
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Orlando, FL
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IMIC
Palmetto Bay, Florida
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Palmetto Bay, FL
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Asclepes Research Centers
14860 Roscoe Boulevard
Panorama City, California 91402
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Panorama City, CA
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Clinical Research Partners, LLC
Petersburg, Virginia 23805
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Petersburg, VA
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Research Across America
Plano, Texas 75093
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Plano, TX
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Carilion Clinic
Roanoke, Virginia
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Roanoke, VA
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Carilion Medical Center
Roanoke, Virginia 24014
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Roanoke, VA
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Finger Lakes Clinical Research
Rochester, New York 14618
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Rochester, NY
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University of California Davis Medical Center MIND Institute
2825 50th Street
Sacramento, California 95817
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Sacramento, CA
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Attalla Consultants LLC dba Institute for Behavioral Medicine
Smyrna, Georgia 30080
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Smyrna, GA
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Family Psychiatry of the Woodlands
The Woodlands, Texas 77381
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The Woodlands, TX
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Sleep and Behavior Medicine Institute
Vernon Hills, Illinois 60061
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Vernon Hills, IL
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Children's National Health System
Washington, District of Columbia 20010
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Washington,
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Elite Clinical Trials, Incorporated
Wildomar, California 92595
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