NCT00088049已完成4 期
A Randomized Double-Blind Study of Olanzapine Versus Aripiprazole in the Treatment of Schizophrenia
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 560
- 试验地点
- 25
- 主要终点
- To determine the long-term effectiveness and tolerability as measured by time to all-cause treatment discontinuation of olanzapine and aripiprazole relative to each other in patients with schizophrenia during 28 weeks of double-blind therapy
研究概览
简要总结
The purpose of the protocol is to evaluate the efficacy of olanzapine compared with Aripiprazole in patients with schizophrenia.
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
- •Male or female inpatient or outpatients, ages 18-65
排除标准
- •Participation in a clinical trial of another drug including olanzapine or aripiprazole within 30 days prior to study entry (visit 1).
- •Treatment with clozapine within the past 12 months.
- •Have known uncorrected narrow-angle glaucoma.
- •Have a diagnosis of Parkinson's disease, dementia or related disorder
结局指标
主要结局
To determine the long-term effectiveness and tolerability as measured by time to all-cause treatment discontinuation of olanzapine and aripiprazole relative to each other in patients with schizophrenia during 28 weeks of double-blind therapy
次要结局
- To assess olanzapine versus aripiprazole in the following:
- improvement in psychopathology of schizophrenia as measured by PANSS change
- change in CGI-S and PGI-I scores
- level of activation as measured by PANSS change
- depressive symptoms as measured by MADRS score
- response rates
- time to failure to maintain response
- quality of life as measured by the SWN-S and SF-36
- cognitive functioning as measured by the MOS
- sexual functioning as measured by the GISF
- health resource utilization and resource utilization costs
- hospitalization time
- treatment emergent adverse events
- EPS as measured by the Simpson-Angus, Barnes, and AIMS
- laboratory values
- vital signs
研究者
研究点 (25)
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