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Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

NCT00265330•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

Summary

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)

Eligibility

Age

10 - 17 years

Sex

ALL

Healthy Volunteers

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.

Locations (41)

Pfizer Investigational Site

Scottsdale, Arizona, United States

Pfizer Investigational Site

San Diego, California, United States

Pfizer Investigational Site

Aurora, Colorado, United States

Pfizer Investigational Site

Altamonte Springs, Florida, United States

Pfizer Investigational Site

Fort Lauderdale, Florida, United States

Pfizer Investigational Site

North Miami, Florida, United States

Pfizer Investigational Site

Orange City, Florida, United States

Pfizer Investigational Site

Tavares, Florida, United States

Pfizer Investigational Site

Decatur, Georgia, United States

Pfizer Investigational Site

Honolulu, Hawaii, United States

Key Dates

Start Date

March 1, 2006

Primary Completion Date

January 1, 2008

Completion Date

January 1, 2008

Last Updated

March 25, 2021

Enrollment

169

ACTUAL participants

Conditions

Bipolar Disorder

Interventions

Ziprasidone oral capsules

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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