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Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)

NCT ID: NCT00257166

Last Updated: 2021-03-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-07-31

Brief Summary

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The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).

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Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ziprasidone oral capsules

Group Type EXPERIMENTAL

Ziprasidone oral capsules

Intervention Type DRUG

Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.

Placebo

Group Type PLACEBO_COMPARATOR

placebo oral capsules

Intervention Type DRUG

Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.

Interventions

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Ziprasidone oral capsules

Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.

Intervention Type DRUG

placebo oral capsules

Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* DSM-IV 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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Scottsdale, Arizona, United States

Site Status

Pfizer Investigational Site

Orange, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Altamonte Springs, Florida, United States

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Fort Lauderdale, Florida, United States

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North Miami, Florida, United States

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Orange City, Florida, United States

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Tavares, Florida, United States

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Decatur, Georgia, United States

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Honolulu, Hawaii, United States

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Des Plaines, Illinois, United States

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Schaumburg, Illinois, United States

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Terre Haute, Indiana, United States

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Lexington, Kentucky, United States

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Owensboro, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Shreveport, Louisiana, United States

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Pikesville, Maryland, United States

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Towson, Maryland, United States

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Towson, Maryland, United States

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Clinton Township, Michigan, United States

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Meridian, Mississippi, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Albuquerque, New Mexico, United States

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Buffalo, New York, United States

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Rochester, New York, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Charleston, South Carolina, United States

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Arlington, Texas, United States

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DeSoto, Texas, United States

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Fort Worth, Texas, United States

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Lake Jackson, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Kirkland, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Pfizer Investigational Site

West Allis, Wisconsin, United States

Site Status

Countries

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United States

References

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Findling RL, Cavus I, Pappadopulos E, Vanderburg DG, Schwartz JH, Gundapaneni BK, DelBello MP. Efficacy, long-term safety, and tolerability of ziprasidone in children and adolescents with bipolar disorder. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):545-57. doi: 10.1089/cap.2012.0029. Epub 2013 Oct 10.

Reference Type DERIVED
PMID: 24111980 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281132&StudyName=Safety%20and%20efficacy%20of%20ziprasidone%20in%20children%20and%20adolescents%20with%20Bipolar%20I%20Disorder%20%28manic%20or%20mixed%29

To obtain contact information for a study center near you, click here.

Other Identifiers

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A1281132

Identifier Type: -

Identifier Source: org_study_id

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