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

NCT ID: NCT00265330

Last Updated: 2021-03-25

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

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-01-31

Brief Summary

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The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in 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

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open

Group Type EXPERIMENTAL

Ziprasidone oral capsules

Intervention Type DRUG

Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .

Interventions

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Ziprasidone oral capsules

Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participation in double-blind treatment study A1281132, meeting specific criteria of duration and safety

Exclusion Criteria

* Imminent risk of suicide or homicide, as judged by the site investigator;serious adverse event related to study medication in study A1281132; significant prolongation of QT interval in study A1281132.
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

San Diego, California, United States

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Pfizer Investigational Site

Aurora, Colorado, United States

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Pfizer Investigational Site

Altamonte Springs, Florida, United States

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Pfizer Investigational Site

Fort Lauderdale, Florida, United States

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Pfizer Investigational Site

North Miami, Florida, United States

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Pfizer Investigational Site

Orange City, Florida, United States

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Pfizer Investigational Site

Tavares, Florida, United States

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Pfizer Investigational Site

Decatur, Georgia, United States

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Honolulu, Hawaii, 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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Shreveport, Louisiana, 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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Rochester, New York, United States

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Cincinnati, Ohio, United States

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Pfizer Investigational Site

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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Pfizer Investigational Site

Oklahoma City, Oklahoma, United States

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Pfizer Investigational Site

Oklahoma City, Oklahoma, United States

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Pfizer Investigational Site

Oklahoma City, Oklahoma, United States

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Pfizer Investigational Site

Tulsa, Oklahoma, United States

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Pfizer Investigational Site

Charleston, South Carolina, United States

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Pfizer Investigational Site

Arlington, Texas, United States

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Pfizer Investigational Site

DeSoto, Texas, United States

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Pfizer Investigational Site

Lake Jackson, Texas, United States

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Pfizer Investigational Site

Plano, Texas, United States

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Pfizer Investigational Site

San Antonio, Texas, United States

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Pfizer Investigational Site

Kirkland, Washington, United States

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Pfizer Investigational Site

Spokane, Washington, United States

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Pfizer Investigational Site

Milwaukee, Wisconsin, United States

Site Status

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=A1281133&StudyName=Safety%20and%20tolerability%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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A1281133

Identifier Type: -

Identifier Source: org_study_id

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