NCT00254787已完成2 期
Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in the Treatment of Patients With Acute Schizophrenia - a Multicentre, Double-Blind, Parallel Group, Randomized Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment
研究概览
简要总结
The purpose of the study is to compare the safety and tolerability of IR (Immediate-Release) quetiapine in a rapid escalation scheme with to the current approved label titration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age ≥18 to ≤65 years with acute schizophrenia
- •Provision of written informed consent prior to enrolment
排除标准
- •Meeting the criteria for any other (than schizophrenia) psychotic disorder not in full remission, concomitant organic mental disorder or mental retardation
- •Patients with substance dependence
- •Female patients who are pregnant, lactating or at risk of pregnancy
结局指标
主要结局
Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment
次要结局
- Safety and Tolerability
- Number and type of adverse events
- Changes in vital signs and weight
- Clinically significant changes in ECG (reported as AE)
- Change of Simpson-Angus Scale (SAS) score
- Change of Barnes Akathisia Rating Scale (BARS) score
研究者
研究点 (6)
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