Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)

Viatris

Status and phase: Withdrawn; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Ziprasidone Oral Capsules; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01117220

A1281196

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 l Disorder (Manic or Mixed).

Sex: All

Ages: 10 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for Bipolar I disorder (manic or mixed)
• At the screening and baseline visits, subjects must have a Young Mania Rating Scale (YMRS) score of at least 17.
• The subject must have a Body Mass Index (BMI) z score between -1.65 and +2.00, inclusive

Exclusion criteria

• Imminent risk of suicide or homicide, as judged by the site investigator
• Any history of serious or unstable illness
• Risk for prolonged QT

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Treatment:

Drug: Placebo

1

Active Comparator group

Treatment:

Drug: Ziprasidone Oral Capsules