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

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

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Bipolar Disorder

Interventions

PlaceboDRUG

Placebo matching the oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dose design with minimal dose range of 40 mg twice a day (BID) to maximum dose range of 80 mg BID (weight specific- \< 45kg max dose 40 mg BID).

Ziprasidone Oral CapsulesDRUG

Oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dose design with minimal dose range of 40 mg twice a day (BID to maximum dose range of 80 mg BID (weight specific- \< 45kg max dose 40 mg BID).

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline to Week 4 in Young Mania Rating Scale (YMRS) total score.

Time frame: 4 weeks

Secondary Outcomes

Change from baseline in Clinical Global Impression of Severity (CGI S) score.

Time frame: 4 weeks

Clinical Global Impression of Improvement (CGI I) score

Time frame: 4 weeks

Data from ClinicalTrials.gov

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