NCT00690365已完成不适用
A Non-interventional, Open Label, Phase IV Observational Study for the Safety and Efficacy of Switching to Quetiapine (Seroquel) in Outpatients With Schizophrenia Who Have Been Unsuccessfully Treated With Other Antipsychotics
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 576
- 主要终点
- Safety of quetiapine assessed through analysis of AE/SAE data (rate of patients presenting SAEs, rate of patients who discontinue treatment due to any AE, time to treatment discontinuation due to any AEs)
研究概览
简要总结
This is a single-arm, phase IV, open-label, prospective, non interventional study in approximately 600 patients that will be followed for 6 months in order to evaluate the safety and efficacy of quetiapine. Patients will be switched over a 4 to 7 day cross-titration period from their previous antipsychotic medication to quetiapine according to the approved SPC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Diagnosis of schizophrenia at least 1 year prior to screening
- •Inadequate response or poor safety /tolerability or non-compliance to previous antipsychotic medication
- •Provision of Informed Consent prior to enrolment
排除标准
- •Known hypersensitivity to active substance of excipients
- •Patients receiving P450 3A4 inhibitors
- •Pregnancy or lactation
- •Substance abuse or dependence
结局指标
主要结局
Safety of quetiapine assessed through analysis of AE/SAE data (rate of patients presenting SAEs, rate of patients who discontinue treatment due to any AE, time to treatment discontinuation due to any AEs)
时间窗: 5 visits (Day 0, Week 1, Week 4, Week 12, Week 24); SAEs will be reported during all study period
次要结局
- Changes in the Clinical Global Impression of Severity and Improvement (CGI-S, CGI-I) and in Brief psychiatric Rating Scale (BPRS) from baseline to end of study treatment(5 visits (Day 0, Week 1, Week 4, Week 12, Week 24))
- Percentage of extra-pyramidal side effects assessed using the Simpson-Angus Scale (SAS)(Changes from baseline to end of study treatment or (6 months) or early withdrawal)
研究者
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