临床试验/NCT00768612

NCT00768612撤回2 期

A Randomized, Double-Blind, Risperidone-Reference, Parallel-Group, Safety, and Tolerability Study of Vabicaserin (SCA-136) in Japanese Subjects With Acute Exacerbation of Schizophrenia

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点开始时间: 2008年11月最近更新: 2013年1月29日

适应症

干预措施

试验速览

阶段: 2 期
状态: 撤回
发起方
主要终点: Positive and Negative Syndrome Scale PANSS

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will evaluate the clinical safety and tolerability of vabicaserin in Japanese subjects that have a sudden worsening of their symptoms of schizophrenia. The study will also assess the efficacy of vabicaserin and compare it to risperidone.

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: 20 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male and female subjects between >=20 and =<65 years of age
•Current diagnosis and DSM-IV-TR diagnosis of schizophrenia type (295.10, 295.30 and 295.90)
•Total PANSS score >=70 and =< 120

排除标准

•Subjects who are hospitalized against their will
•Current Axis I primary psychiatric diagnosis other than schizophrenia
•A score of 3 on CDSS question 8 which pertains to suicide

研究组 & 干预措施

1

Experimental

Lowest dose

干预措施: SCA-136 50mg/day (Drug)

2

Experimental

Middle dose

干预措施: SCA-136 150 mg/day (Drug)

3

Experimental

Highest dose

干预措施: SCA-136 300mg/day (Drug)

4

Active Comparator

Positive Control

干预措施: Risperidone 4mg/day (Drug)

结局指标

主要结局

Positive and Negative Syndrome Scale PANSS

时间窗: 6 week

次要结局

Calgary Depression Scale for Schizophrenia CDSS(6 week)

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

责任方

Sponsor

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