NCT00926393已完成4 期
A Phase IV, Multi-center, Double-blind, Double-dummy, Randomized, Parallel-group Study to Compare the Tolerability of Quetiapine Fumarate Immediate Release (Seroquel IR) With Quetiapine Fumarate Extended Release (Seroquel XR) During Initial Dose Escalation in Patients With Bipolar Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 139
- 主要终点
- Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)
研究概览
简要总结
The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV-TR documented bipolar I or bipolar II, most recent episode depressed
- •Outpatient status as enrollment
排除标准
- •Other than bipolar disorder under study, patients must not have another current, major disorder that is symptomatic or has required treatment within 6 months of enrollment.
研究组 & 干预措施
Quetiapine Immediate Release (IR)
Active Comparator
Quetiapine 25, 100, 200 and 300 mg
干预措施: Quetiapine Immediate Release (Drug)
Quetiapine Extended Release (XR)
Active Comparator
Quetiapine 50, 200, 300
干预措施: Quetiapine Extended Release (Drug)
结局指标
主要结局
Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)
时间窗: At 1 hour post-dose, Day 2 (50 mg)
The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.
次要结局
- Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)(At 1 hour post-dose, Day 3 (100 mg))
- Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)(At 1 hour post-dose, Day 4 (200 mg))
- Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)(At 1 hour post-dose, Day 5 (300 mg))
- Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)(At 1 hour post-dose, Day 6 (300 mg))
- Maximum Intensity Modified Bond-Lader Visual Analog Scale Score(During Day 2 (50 mg))
- Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score(During Day 2 (50 mg))
- Area Under the Modified Bond-Lader Visual Analog Scale-time Curve(During Day 2 (50 mg))
- Change in Simpson-Angus Scale (SAS) Total Score(Randomization to Day 7)
- Change in Barnes Akathisia Rating Scale (BARS) Global Score(Randomization to Day 7)
- Change in Abnormal Involuntary Movement Scale (AIMS) Total Score(Randomization to Day 7)
- Number of Patients With Potential Extrapyramidal Symptoms (EPS)(From start of the study treatment to last dose plus 30 days)
- Number of Patients With Potential Somnolence(From start of the study treatment to last dose plus 30 days)
研究者
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