Safety and Tolerability 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: Ziprasidone oral capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT00265330

A1281133

Details and patient eligibility

About

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)

Enrollment: 169 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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169 participants in 1 patient group

Open

Experimental group

Treatment:

Drug: Ziprasidone oral capsules