NCT00073164已完成2 期
A Study of the Safety and Efficacy of Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 400
- 试验地点
- 35
- 主要终点
- The psychiatric rating scale battery will include the PANSS, the CGI Scale, and the CDSS. The NOSIE, Overall Treatment Evaluation, Burden Questionnaire, and Quality of Life Scale.
研究概览
简要总结
The purpose of this study is to assess the 14-day and 12-week safety and efficacy of Depakote ER used in combination with either olanzapine or risperidone versus antipsychotic monotherapy with olanzapine or risperidone for the treatment of 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
The psychiatric rating scale battery will include the PANSS, the CGI Scale, and the CDSS. The NOSIE, Overall Treatment Evaluation, Burden Questionnaire, and Quality of Life Scale.
次要结局
- The movement rating scale battery will include the Simpson-Angus Scale (SAS), the Barnes Akathisia Scale (BAS), and the Abnormal Involuntary Movement Scale (AIMS).
研究者
研究点 (35)
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