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
Medical Research Group of Central Florida
Orange City, Florida 32763
2179
mi
from 91732
Orange City, FL
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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...
2302
mi
from 91732
Baltimore, MD
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California Pharmaceutical Research Institute, Inc
Anaheim, California 92804
17
mi
from 91732
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...
1919
mi
from 91732
Atlanta, GA
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Atlanta Behavioral Research, LLC
2150 Peachford Road
Atlanta, Georgia 30338
1922
mi
from 91732
Atlanta, GA
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Hugo W. Moser Research Institute at Kennedy Krieger Institute Clinical Trials Unit
Baltimore, Maryland 21205
2301
mi
from 91732
Baltimore, MD
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Kennedy Krieger Institute Inpatient Clinic
707 North Broadway
Baltimore, Maryland 21205
2302
mi
from 91732
Baltimore, MD
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Johns Hopkins Hospital Pediatric Clinical Research Unit
Baltimore, Maryland 21231
2301
mi
from 91732
Baltimore, MD
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Charlotte R. Bloomberg Children's Center
1800 Orleans Street
Baltimore, Maryland 21287
2302
mi
from 91732
Baltimore, MD
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Kennedy Krieger Institute Outpatient Clinic
707 North Broadway
Baltimore, Maryland 21205
2302
mi
from 91732
Baltimore, MD
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Psychiatric Mental Health Program at Kennedy Krieger Institute Clinical Trials Unit
Baltimore, Maryland 21205
?
mi
from 91732
Baltimore, MD
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Johns Hopkins Hospital Investigational Drug Services
1800 Orleans Street
Baltimore, Maryland 21287
2302
mi
from 91732
Baltimore, MD
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Da Vinci Research Institute Inc
Boca Raton, Florida 33487
2310
mi
from 91732
Boca Raton, FL
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Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
Buffalo, New York 14215
2181
mi
from 91732
Buffalo, NY
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UVA Child & Family Psychiatry Clinic
Charlottesville, Virginia 22903
2208
mi
from 91732
Charlottesville, VA
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Northridge Medical Plaza
1215 Lee Street
Charlottesville, Virginia 22903
2207
mi
from 91732
Charlottesville, VA
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University of Virginia Center for Psychopharmacology Research in Youth
Charlottesville, Virginia 22903
2206
mi
from 91732
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...
1880
mi
from 91732
Cincinnati, OH
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University Hospitals Case Medical Center Division of Child and Adolescent Psychiatry
Cleveland, Ohio 44106
2032
mi
from 91732
Cleveland, OH
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CMB Clinical Trials
2068 Orange Tree Lane
Colton, California 92374
45
mi
from 91732
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...
1959
mi
from 91732
Columbus, OH
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Harmonex Neuroscience Research
Dothan, Alabama 36303
1898
mi
from 91732
Dothan, AL
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Core Clinical Research
Everett, Washington 98201
984
mi
from 91732
Everett, WA
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Eaastside Therapeutic dba Core Clinical Research
Everett, Washington 98201
?
mi
from 91732
Everett, WA
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Eastside Therapeutic dba Core Clinical Research
Everett, Washington 98201
?
mi
from 91732
Everett, WA
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Inova Clinical Trials and Research Centre
Fayetteville, Georgia 30214
1919
mi
from 91732
Fayetteville, GA
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Sarkis Clinical Trials
Gainesville, Florida 32607
2101
mi
from 91732
Gainesville, FL
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Rakesh Ranjan, MD & Associates Inc.
Garfield Heights, Ohio 44125
2036
mi
from 91732
Garfield Heights, OH
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The Zucker Hillside Hospital Northwell Health
75-59 263rd Street
Glen Oaks, New York 11004
2448
mi
from 91732
Glen Oaks, NY
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UT Health Science Center at Houston (UTHSC-H)
Houston, Texas 77054
1357
mi
from 91732
Houston, TX
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Woodland International Research Group, Inc.
Little Rock, Arkansas 72211
1463
mi
from 91732
Little Rock, AR
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Clinical Research Integrity(CRI) Lifetree, LLC
401 New Jersey 73
Marlton, New Jersey 08053
2387
mi
from 91732
Marlton, NJ
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PRA Health Sciences
Marlton, New Jersey 08053
2388
mi
from 91732
Marlton, NJ
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Manhattan Behavioral Medicine, LLC
New York, New York 10022
2434
mi
from 91732
New York, NY
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Sooner Clinical Research
Oklahoma City, Oklahoma 73112
1161
mi
from 91732
Oklahoma City, OK
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Cutting Edge Research Group
Oklahoma City, Oklahoma 73116
1162
mi
from 91732
Oklahoma City, OK
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Paradigm Research Professionals, Llc
Oklahoma City, Oklahoma 73112
1164
mi
from 91732
Oklahoma City, OK
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NRC Research Institute
Orange, California 92868
21
mi
from 91732
Orange, CA
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APG Research, LLC
Orlando, Florida 32803
2185
mi
from 91732
Orlando, FL
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IMIC
Palmetto Bay, Florida
2318
mi
from 91732
Palmetto Bay, FL
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Asclepes Research Centers
14860 Roscoe Boulevard
Panorama City, California 91402
27
mi
from 91732
Panorama City, CA
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Clinical Research Partners, LLC
Petersburg, Virginia 23805
2273
mi
from 91732
Petersburg, VA
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Research Across America
Plano, Texas 75093
1219
mi
from 91732
Plano, TX
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Carilion Clinic
Roanoke, Virginia
2133
mi
from 91732
Roanoke, VA
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Carilion Medical Center
Roanoke, Virginia 24014
2133
mi
from 91732
Roanoke, VA
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Finger Lakes Clinical Research
Rochester, New York 14618
2248
mi
from 91732
Rochester, NY
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University of California Davis Medical Center MIND Institute
2825 50th Street
Sacramento, California 95817
363
mi
from 91732
Sacramento, CA
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Attalla Consultants LLC dba Institute for Behavioral Medicine
Smyrna, Georgia 30080
1911
mi
from 91732
Smyrna, GA
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Family Psychiatry of the Woodlands
The Woodlands, Texas 77381
1344
mi
from 91732
The Woodlands, TX
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Sleep and Behavior Medicine Institute
Vernon Hills, Illinois 60061
1716
mi
from 91732
Vernon Hills, IL
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Children's National Health System
Washington, District of Columbia 20010
2281
mi
from 91732
Washington,
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Elite Clinical Trials, Incorporated
Wildomar, California 92595
53
mi
from 91732
Wildomar, CA
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