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)
Overview
- Phase
- Phase 3
- Intervention
- ziprasidone oral capsules
- Conditions
- Bipolar Disorder
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary Endpoint
- 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)
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subjects must have received study medication in Study A
- •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.
Arms & Interventions
Open
Intervention: ziprasidone oral capsules
Outcomes
Primary Outcomes
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)
Time Frame: weeks 1, 2, 6, 10, 14, 18, 22, and 26
Change from baseline in Physical exam
Time Frame: week 26
Change from baseline in Clinical laboratory tests
Time Frame: weeks 2, 6, 18,26
Change from baseline in body weight, height, BMI, BMI z score, and waist circumference
Time Frame: 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)
Time Frame: weeks 1, 2, 6, 10, 14, 18, 22, and 26
Secondary Outcomes
- 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)