A 26-week, Multicenter, Open-label Phase 3b Study of the Safety and Tolerability of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets in Daily Doses of 400 mg to 800 mg in Children and Adolescents With Bipolar I Disorder and Adolescents With Schizophrenia (Abbreviated)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 381
- 试验地点
- 49
- 主要终点
- Incidence and Nature of Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patient is able to provide written assent and the parents or legal guardian of the patient are/is able to provide written informed consent before beginning any study related procedures
- •Patient previously enrolled in either double-blind Study D1441C00149 or D1441C00112
- •Patient has documented clinical diagnosis of schizophrenia or bipolar I disorder
- •Patient's parent or legal guardian will be able to accompany the patient to each scheduled study visit
排除标准
- •Patients (female) must not be pregnant or lactating
- •Patients with a known intolerance or lack of response to previous treatment with quetiapine
- •Patients who have previously participated in this study
结局指标
主要结局
Incidence and Nature of Adverse Events (AEs)
时间窗: from open label to week 26+ 30 days
Number of participants that had AE which occurred from first dose date to last dose date + 30 days.
Number of Patients Withdrawn Due to AEs.
时间窗: during 26 weeks of treatment
Number of subjects who withdrew from the study due to AEs.
Change From Baseline in Weight
时间窗: 26 weeks of treatment
Number with 7% or more increase (without adjustment for normal growth)
Change From Baseline in Supine Pulse
时间窗: OL baseline to week 26
Change from OL baseline to week 26 in supine pulse (bpm)
Change From OL Baseline in Supine Diastolic BP.
时间窗: OL baseline to Week 26
Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)
Changes in Laboratory Test Results (Prolactin)
时间窗: Duration of study participation
Clinical important shift to high prolactin from open-label (OL) baseline to week 26. High Prolactin is defined as value \>26 ug/L for female and value \>20 ug/L for male.
Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score
时间窗: OL baseline to week 26
Number of patients for who the total score is estimated as worse. The Simpson Angus Scale (SAS)is used to assess Parkinsonian symptoms (a type of movement disorders). The score was calculated as the sum of the 10 individual item scores. Total Score ranges from 0-40 (normal to worse). Individual item scale range from 0 to 4 (normal to worse). Improved define as those with a \<= -1 change in SAS total score. Worsened defined as those with a \>=1 change in SAS total score.
Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score
时间窗: 26 weeks of treatment
Number of patients for who the total score is estimated as worse. The Barnes Akathisia Rating Scale (BARS) global score is used to measure Akathisia (a type of movement disorders). BARS is the item 4 score from the BARS assessment. The scale is from a range 0-5 (normal to worse). Change from baseline in BARS global score increase means worse. Improved defined as those with a \<= -1 change in BARS global score. Worsened defined as those with a \>= 1 change in BARS global score.
Change From OL Baseline in Supine Systolic BP.
时间窗: OL baseline to Week 26
Changes from OL baseline to the final visits in Supine systolic BP (mmHg)
次要结局
- Changes in Tanner Stage(Change from OL baseline to week 26 in the Tanner stage)
- Change From Baseline in Children's Global Assessment Scale (CGAS) Score(OL Baseline to Week 26)