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

26 Week Open Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

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).

Study Overview

• Status: Withdrawn
• Conditions: Bipolar Disorder
• Intervention / Treatment: Drug: ziprasidone oral capsules

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open	Drug: ziprasidone oral capsules; Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength will be provided. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID.; Other Names: Zeldox, Geodon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 School Placement 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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: May 14, 2010
• First Submitted That Met QC Criteria: May 14, 2010
• First Posted (Estimate): May 17, 2010

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Children and Adolescents with Bipolar I Disorder (manic or mixed)
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Disease; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Ziprasidone
• Other Study ID Numbers: A1281197