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

Phase 3

Withdrawn

• Conditions: Bipolar Disorder
• Interventions: Drug: Ziprasidone Oral Capsules; Drug: Placebo

• Registration Number: NCT01117220
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-05
• Study Start: 2010-06
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ziprasidone Oral Capsules	-
2	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Clinical Global Impression of Severity (CGI S) score.	4 weeks
Clinical Global Impression of Improvement (CGI I) score	4 weeks