Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

Phase 3

Withdrawn

• Conditions: Bipolar Disorder
• Interventions: Drug: ziprasidone oral capsules

• Registration Number: NCT01124877
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

The purpose of this study is to assess the safety and tolerability of ziprasidone during a long-term open label study in children and adolescents (ages 10-17) with Bipolar I Disorder (Manic or Mixed).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-14
• Study First Submitted QC: 2010-05-14
• Study First Posted: 2010-05-17
• Study Start: 2010-07
• Primary Completion: 2011-10
• Study Completion: 2011-10
• 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• Status: WITHDRAWN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

• The subjects must have received study medication in Study A1281196.
• In the investigator's opinion, the subject must be likely to continue to benefit from antipsychotic therapy and must have been free from any clinically significant safety concerns during the preceding double blind study.

Exclusion Criteria

• Subjects who require treatment with drugs that are known to consistently prolong the QT interval.
• Subjects who are judged by the investigator as being at imminent risk of suicide.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open	ziprasidone oral capsules	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in blood pressure and pulse Change from baseline in electrocardiogram (QTc) Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S)	weeks 1, 2, 6, 10, 14, 18, 22, and 26
Change from baseline in Physical exam	week 26
Change from baseline in Clinical laboratory tests	weeks 2, 6, 18,26
Change from baseline in body weight, height, BMI, BMI z score, and waist circumference	weeks 6, 26
Adverse events -Only number of subjects with adverse events or serious adverse events Columbia Suicide Severity Rating Scale Change from Baseline in Child Depression Rating Scale - Revised (CDRS-R)	weeks 1, 2, 6, 10, 14, 18, 22, and 26

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in School Placement Questionnaire	weeks 6 and 26
Change from Baseline in Young Mania Rating Scale (YMRS)	weeks 2, 6, 18, and 26
Change from Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ)	weeks 2, 6, 18, and 26
Change from Baseline in Child Health Questionnaire	weeks 6 and 26
Change from Baseline in CNS Vital Signs Cognitive Test Battery	weeks 6 and 26
Change from Baseline in CNS Vital Signs Cognitive Test Sedation Item	weeks 6 and 26
Change from Baseline in Simpson-Angus Rating Scale (SARS)	weeks 1, 2, 6, 10, 14, 18, 22 and 26
Change from Baseline in Barnes Akathisia Rating Scale (BAS)	weeks 1, 2, 6, 10, 14, 18, 22 and 26
Change from Baseline in Abnormal Involuntary Movement Scale (AIMS)	weeks 1, 2, 6, 10, 14, 18, 22 and 26
Change from Baseline in Childrens Global Assessment Scales	weeks 2, 6, 18, and 26
Change from Baseline in Tanner Adolescent Pubertal Self-Assessment	26 weeks