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)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- 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)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Open
干预措施: ziprasidone oral capsules (Drug)
结局指标
主要结局
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)
时间窗: weeks 1, 2, 6, 10, 14, 18, 22, and 26
Change from baseline in Physical exam
时间窗: week 26
Change from baseline in Clinical laboratory tests
时间窗: weeks 2, 6, 18,26
Change from baseline in body weight, height, BMI, BMI z score, and waist circumference
时间窗: 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)
时间窗: weeks 1, 2, 6, 10, 14, 18, 22, and 26
次要结局
- 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)