NCT00852631终止3 期
Open-label Multicentre Study on Efficacy and Safety of Oral Quetiapine (Seroquel XR) in Adults With Schizophrenia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Change in Positive and Negative Syndrome Scale (PANSS) Total Score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Seroquel XR in schizophrenia patients with acute worsening symptoms. Consequently, to assess whether the study drug is safe and acceptable on the daily dose basis, orally given, up to 600 mg once a day for 42 days.
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
- 是
入选标准
- •Patient meets the DSM-IV criteria for schizophrenia
- •Patient has a PANSS total score ≥ 70 at baseline
- •Patient has a CGI-S score of ≥ 4(moderately ill) at baseline
- •Patient is healthy on the basis of physical examination and vital signs at baseline
排除标准
- •Positive urine drug screen for Opiates, amphetamine, barbiturate, cocaine, cannabis, or ecstasy abuse
- •Has history of neuroleptic malignant syndrome, seropositive for anti-HIV, hepatitis B or C virus antigen
- •Patient with unstable or inadequately treated Diabetes Mellitus
- •Use of potent cytochrome P450 inhibitors or inducer within 14 days before baseline
结局指标
主要结局
Change in Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: From Day 1 (baseline) to Day 42
Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210. Minimum value considered better is score decreased from baseline at least 30%.
次要结局
- Change in Clinical Global Impression - Severity of Illness (CGI-S) Score(From Day 1 (Baseline) to Day 42)
- Clinical Global Impression - Severity of Illness (CGI-S) Score(Day 14)
研究者
研究点 (4)
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