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
Atlanta Behavioral Research, LLC
2150 Peachford Road
Atlanta, Georgia 30338
423
mi
from 43215
Atlanta, GA
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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...
345
mi
from 43215
Baltimore, MD
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California Pharmaceutical Research Institute, Inc
Anaheim, California 92804
1963
mi
from 43215
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...
434
mi
from 43215
Atlanta, GA
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Hugo W. Moser Research Institute at Kennedy Krieger Institute Clinical Trials Unit
Baltimore, Maryland 21205
344
mi
from 43215
Baltimore, MD
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Kennedy Krieger Institute Inpatient Clinic
707 North Broadway
Baltimore, Maryland 21205
345
mi
from 43215
Baltimore, MD
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Johns Hopkins Hospital Pediatric Clinical Research Unit
Baltimore, Maryland 21231
344
mi
from 43215
Baltimore, MD
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Charlotte R. Bloomberg Children's Center
1800 Orleans Street
Baltimore, Maryland 21287
345
mi
from 43215
Baltimore, MD
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Kennedy Krieger Institute Outpatient Clinic
707 North Broadway
Baltimore, Maryland 21205
345
mi
from 43215
Baltimore, MD
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Psychiatric Mental Health Program at Kennedy Krieger Institute Clinical Trials Unit
Baltimore, Maryland 21205
?
mi
from 43215
Baltimore, MD
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Johns Hopkins Hospital Investigational Drug Services
1800 Orleans Street
Baltimore, Maryland 21287
345
mi
from 43215
Baltimore, MD
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Da Vinci Research Institute Inc
Boca Raton, Florida 33487
951
mi
from 43215
Boca Raton, FL
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Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
Buffalo, New York 14215
295
mi
from 43215
Buffalo, NY
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UVA Child & Family Psychiatry Clinic
Charlottesville, Virginia 22903
278
mi
from 43215
Charlottesville, VA
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Northridge Medical Plaza
1215 Lee Street
Charlottesville, Virginia 22903
277
mi
from 43215
Charlottesville, VA
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University of Virginia Center for Psychopharmacology Research in Youth
Charlottesville, Virginia 22903
276
mi
from 43215
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...
98
mi
from 43215
Cincinnati, OH
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University Hospitals Case Medical Center Division of Child and Adolescent Psychiatry
Cleveland, Ohio 44106
126
mi
from 43215
Cleveland, OH
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CMB Clinical Trials
2068 Orange Tree Lane
Colton, California 92374
1917
mi
from 43215
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...
2
mi
from 43215
Columbus, OH
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Harmonex Neuroscience Research
Dothan, Alabama 36303
616
mi
from 43215
Dothan, AL
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Core Clinical Research
Everett, Washington 98201
2001
mi
from 43215
Everett, WA
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Eaastside Therapeutic dba Core Clinical Research
Everett, Washington 98201
?
mi
from 43215
Everett, WA
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Eastside Therapeutic dba Core Clinical Research
Everett, Washington 98201
?
mi
from 43215
Everett, WA
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Inova Clinical Trials and Research Centre
Fayetteville, Georgia 30214
457
mi
from 43215
Fayetteville, GA
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Sarkis Clinical Trials
Gainesville, Florida 32607
713
mi
from 43215
Gainesville, FL
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Rakesh Ranjan, MD & Associates Inc.
Garfield Heights, Ohio 44125
124
mi
from 43215
Garfield Heights, OH
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The Zucker Hillside Hospital Northwell Health
75-59 263rd Street
Glen Oaks, New York 11004
493
mi
from 43215
Glen Oaks, NY
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UT Health Science Center at Houston (UTHSC-H)
Houston, Texas 77054
996
mi
from 43215
Houston, TX
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Woodland International Research Group, Inc.
Little Rock, Arkansas 72211
622
mi
from 43215
Little Rock, AR
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Clinical Research Integrity(CRI) Lifetree, LLC
401 New Jersey 73
Marlton, New Jersey 08053
428
mi
from 43215
Marlton, NJ
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PRA Health Sciences
Marlton, New Jersey 08053
429
mi
from 43215
Marlton, NJ
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Manhattan Behavioral Medicine, LLC
New York, New York 10022
479
mi
from 43215
New York, NY
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Sooner Clinical Research
Oklahoma City, Oklahoma 73112
850
mi
from 43215
Oklahoma City, OK
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Cutting Edge Research Group
Oklahoma City, Oklahoma 73116
849
mi
from 43215
Oklahoma City, OK
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Paradigm Research Professionals, Llc
Oklahoma City, Oklahoma 73112
849
mi
from 43215
Oklahoma City, OK
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NRC Research Institute
Orange, California 92868
1959
mi
from 43215
Orange, CA
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Medical Research Group of Central Florida
Orange City, Florida 32763
767
mi
from 43215
Orange City, FL
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APG Research, LLC
Orlando, Florida 32803
794
mi
from 43215
Orlando, FL
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IMIC
Palmetto Bay, Florida
1003
mi
from 43215
Palmetto Bay, FL
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Asclepes Research Centers
14860 Roscoe Boulevard
Panorama City, California 91402
1979
mi
from 43215
Panorama City, CA
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Clinical Research Partners, LLC
Petersburg, Virginia 23805
357
mi
from 43215
Petersburg, VA
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Research Across America
Plano, Texas 75093
901
mi
from 43215
Plano, TX
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Carilion Clinic
Roanoke, Virginia
249
mi
from 43215
Roanoke, VA
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Carilion Medical Center
Roanoke, Virginia 24014
249
mi
from 43215
Roanoke, VA
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Finger Lakes Clinical Research
Rochester, New York 14618
356
mi
from 43215
Rochester, NY
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University of California Davis Medical Center MIND Institute
2825 50th Street
Sacramento, California 95817
2041
mi
from 43215
Sacramento, CA
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Attalla Consultants LLC dba Institute for Behavioral Medicine
Smyrna, Georgia 30080
427
mi
from 43215
Smyrna, GA
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Family Psychiatry of the Woodlands
The Woodlands, Texas 77381
974
mi
from 43215
The Woodlands, TX
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Sleep and Behavior Medicine Institute
Vernon Hills, Illinois 60061
301
mi
from 43215
Vernon Hills, IL
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Children's National Health System
Washington, District of Columbia 20010
327
mi
from 43215
Washington,
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Elite Clinical Trials, Incorporated
Wildomar, California 92595
1932
mi
from 43215
Wildomar, CA
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