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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

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).

Key facts

Study ID

NCT02075047

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

171

Starts

2014-05-23

Expected to finish

2020-05-18

Last updated by the study team

2021-06-16

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• DSM V criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years.

You may not qualify if…

• 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.

Where it is running

• Harmonex Neuroscience Research, Inc. — Dothan, Alabama, United States
• Woodland International Research Group Inc. — Little Rock, Arkansas, United States
• Woodland International Research Group, LLC — Little Rock, Arkansas, United States
• California Pharmaceutical Research Institute — Anaheim, California, United States
• NRC Research Institute — Orange, California, United States
• Asclepes Research Centers — Panorama City, California, United States
• University of California Davis Medical Center MIND Institute — Sacramento, California, United States
• Elite Clinical Trials, Incorporated — Wildomar, California, United States
• Children's National Health System — Washington D.C., District of Columbia, United States
• Da Vinci Research Institute Inc — Boca Raton, Florida, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Medical Research Group of Central Florida — Orange City, Florida, United States
• APG Research LLC — Orlando, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Inova Clinical Trials and Research Centre — Fayetteville, Georgia, United States
• Attalla Consultants, LLC dba Institute for Behavioral Medicine — Smyrna, Georgia, United States
• Sleep and Behavior Medicine Institute — Vernon Hills, Illinois, United States
• Hugo W. Moser Research Institute at Kennedy Krieger Institute Clinical Trials Unit — Baltimore, Maryland, United States
• Kennedy Krieger Institute Inpatient Clinic — Baltimore, Maryland, United States
• Kennedy Krieger Institute Outpatient Clinic — Baltimore, Maryland, United States
• Psychiatric Mental Health Program at Kennedy Krieger Institute Clinical Trials Unit — Baltimore, Maryland, United States
• Johns Hopkins Hospital Pediatric Clinical Research Unit — Baltimore, Maryland, United States
• Charlotte R. Bloomberg Children's Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital Investigational Drug Services — Baltimore, Maryland, United States
• Clinical Research Integrity(CRI) Lifetree, LLC — Marlton, New Jersey, United States

Full record on ClinicalTrials.gov

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