NCT00265551已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Olanzapine-Referenced, Parallel Group Safety, Efficacy, and Tolerability Study of SCA-136 in Subjects With Acute Exacerbations of Schizophrenia
Wyeth is now a wholly owned subsidiary of Pfizer35 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 35
- 主要终点
- Change from baseline to day 42 on the positive subscale of the SCI-PANNS
研究概览
简要总结
The purpose of this study is to determine whether a low dose and a high dose of the study drug SCA-136 are effective and safe in the treatment of schizophrenia requiring hospitalization.
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
- •Clinical diagnosis of schizophrenia
- •Ability to remain hospitalized for at least first 4 weeks of study
- •Needs hospitalization due to worsening of schizophrenia
排除标准
- •Type 1 or 2 diabetes
- •Previous use of clozapine
- •Serious medical illness other than schizophrenia
结局指标
主要结局
Change from baseline to day 42 on the positive subscale of the SCI-PANNS
次要结局
- Change from baseline to day 42 on:
- SCI-PANNS total score
- negative symptom sub-scale score of SCI-PANNS
- general psychopathology subscale score of SCI-PANNS
- response rate based upon SCI-PANNS total score
- BPRS score
- CGI-S score
- CGI-I score
- Cognitive assessments scores
研究者
研究点 (35)
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