Safety and Efficacy of Seroquel in First Episode Schizophrenia

AstraZeneca1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2002年5月最近更新: 2009年6月11日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: AstraZeneca
入组人数: 80
试验地点: 1
主要终点: The proportion of patients developing clinically significant EPS at any point between baseline (day 1) and final assessment

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To compare the safety, tolerability and efficacy of Seroquel and risperidone in first episode 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: Single

入排标准

年龄范围: 18 Years 至 35 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age 18-35 years Meet ICD-10 criteria for schizophrenia No abnormaility on clinical examination No previous episode of psychosis No previous antipsychotics of any kind in last 3 months

排除标准

•Have received a course of antipsychotics drug treatment prior to entry which may introduce risk factors or interfere with study procedures Have received anticholinergics within 10 days of baseline aseessment Have received mood stabilizers or anti depressants within 2 weeks

结局指标

主要结局

The proportion of patients developing clinically significant EPS at any point between baseline (day 1) and final assessment

次要结局

CGI severity of illness
CGI global improvement
PANSS total score and subscales)
Abnormal Involuntary Movement Scale (AIMS)
Dose of anti cholinergic medication
Serum prolactin levels
Proportion of patients discontinuing treatment due to reasons of lack of efficacy or adverse effects
Proportion of patients experiencing relapse.

研究者

发起方

AstraZeneca

申办方类型

Industry

研究点 (1)

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