A 3 Weeks Open Label Study to Evaluate the Efficacy in Agitation and Safety of Quetiapine Fumarate XR in Treatment of Patients With Acute Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score
研究概览
简要总结
The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR) tablets for 3 weeks will improve their agitation when they have acute psychosis.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requirement for treatment of acute episode of schizophrenia (according to DSM-IV diagnostic criteria)
- •PANSS total score of ³ 75
排除标准
- •Any DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th Edition) Axis I disorder not defined in the inclusion criteria
- •Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- •Substance or alcohol dependence at enrollment
研究组 & 干预措施
Quetiapine XR
Quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards.
干预措施: Quetiapine XR (Seroquel XR) (Drug)
结局指标
主要结局
Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score
时间窗: Baseline and Day 21
PANSS- Excited Component (EC) subscale score will be calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14). This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation). Lower value gives the better outcome.
次要结局
- Change From Baseline to Final Visit at Day 21 in PANSS Positive, General Psychopathological Scores.(Baseline and Day 21)
- Change From Baseline to Final Visit at Day 21 in PANSS Negative, General Psychopathological Scores(Baseline and Day 21)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score(Baseline and Day 21)
- Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S)(Baseline and Day 21)
- Change From Baseline in Absolute Clinical Global Impression-Improvement (CGI-I) Scale(Baseline and Day 21)
- Change of the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score Compared From Baseline to Day 21.(Baseline and Day 21)