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

Bipolar Disorder Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01124877
• Other study ID #: A1281197
• Status: Withdrawn
• Phase: Phase 3
• Start date: July 2010
• Est. completion date: October 2011

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from baseline in Physical exam		week 26
Primary	Change from baseline in Clinical laboratory tests		weeks 2, 6, 18,26
Primary	Change from baseline in body weight, height, BMI, BMI z score, and waist circumference		weeks 6, 26
Primary	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	Change from Baseline in Young Mania Rating Scale (YMRS)		weeks 2, 6, 18, and 26
Secondary	Change from Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ)		weeks 2, 6, 18, and 26
Secondary	Change from Baseline in Child Health Questionnaire		weeks 6 and 26
Secondary	Change from Baseline in School Placement Questionnaire		weeks 6 and 26
Secondary	Change from Baseline in CNS Vital Signs Cognitive Test Battery		weeks 6 and 26
Secondary	Change from Baseline in CNS Vital Signs Cognitive Test Sedation Item		weeks 6 and 26
Secondary	Change from Baseline in Simpson-Angus Rating Scale (SARS)		weeks 1, 2, 6, 10, 14, 18, 22 and 26
Secondary	Change from Baseline in Barnes Akathisia Rating Scale (BAS)		weeks 1, 2, 6, 10, 14, 18, 22 and 26
Secondary	Change from Baseline in Abnormal Involuntary Movement Scale (AIMS)		weeks 1, 2, 6, 10, 14, 18, 22 and 26
Secondary	Change from Baseline in Childrens Global Assessment Scales		weeks 2, 6, 18, and 26
Secondary	Change from Baseline in Tanner Adolescent Pubertal Self-Assessment		26 weeks

External Links

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