Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder

Viatris

Status and phase: Terminated; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: ziprasidone oral capsules; Drug: placebo oral capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT02075047

A1281198

Details and patient eligibility

About

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

Enrollment: 171 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• DSM V 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: Triple Blind

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171 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: placebo oral capsules

ziprasidone

Experimental group

Treatment:

Drug: ziprasidone oral capsules