Population Pharmacokinetic Study in Adolescent Patients With Schizophrenia or Bipolar I Disorder Treated With Olanzapine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 18
- 主要终点
- To characterize olanzapine pharmacokinetics
研究概览
简要总结
The purpose of this study is to characterize olanzapine pharmacokinetics: the inter- and intra- subject variabilities of olanzapine pharmacokinetics; and the potential influence of patient factors such as age, weight, gender, origin, and smoking status on olanzapine pharmacokinetics in adolescents with schizophrenia or bipolar I disorder. This study will also assess the safety of olanzapine delivered orally.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, 13 through 17 years of age (must not have reached their 18th birthday prior to Visit 1).
- •Female patients must not be pregnant or nursing.
- •Patient and patient's parent/authorized legal representative must have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must have given informed consent.
- •Patient must have a previously documented diagnosis of schizophrenia or bipolar I according to the DSM-IV-TR, and either confirmed previously by K-SADS-PL or be confirmed by K-SADS-PL at Visit 1.
排除标准
- •Patients must not be experiencing acute, serious, or unstable medical conditions other than schizophrenia or bipolar I disorder.
- •Patients are not allowed into the study if they currently meet the criteria for the depressed phase of bipolar disorder or are diagnosed with Bipolar II Disorder.
结局指标
主要结局
To characterize olanzapine pharmacokinetics
The inter- and intra-subject variabilities of olanzapine pharmacokinetics
The potential influence of patient factors such as age, weight, gender, origin, and smoking status on olanzapine pharmacokinetics in adolescents 13-17 years of age that have been diagnosed with schizophrenia or bipolar I disorder
次要结局
- To assess the safety of olanzapine delivered orally by measuring adverse events, change in vital signs, weight, laboratory analytes, electrocardiogram (ECG), and severity of extrapyramidal symptoms
- To assess the effect of olanzapine on overall symptomatology