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
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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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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Johns Hopkins Hospital Pediatric Clinical Research Unit
Baltimore, Maryland 21231
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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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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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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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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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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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Elite Clinical Trials, Incorporated
Wildomar, California 92595
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