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

Viatris

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: placebo oral capsules; Drug: Ziprasidone oral capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT00257166

A1281132

Details and patient eligibility

About

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).

Enrollment: 238 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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238 participants in 2 patient groups, including a placebo group

Ziprasidone oral capsules

Experimental group

Treatment:

Drug: Ziprasidone oral capsules

Placebo

Placebo Comparator group

Treatment:

Drug: placebo oral capsules