NCT00305422已完成3 期
Efficacy of Quetiapine Compared to Risperidone on Negative Symptoms and Cognition With Regard to Underlying Neurobiological Mechanisms and Brain Activation.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Clinical efficacy of both neuroleptics, especially with regard to cognitive deficits and functional brain activation between baseline and week 12
研究概览
简要总结
The purpose of the study is to investigate the outcome on negative symptoms of schizophrenic patients during therapy with quetiapine or 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •men and women aged 18 to 65 years with diagnosis of schizophrenia
- •score of at least 4 CGI, PANSS negative subscale score > 21
- •fulfil the criterion to be right-handed for inclusion in the fMRI investigations
排除标准
- •Substance or alcohol dependence
- •female patients who are pregnant, lactating or at risk of pregnancy
- •history of organic CNS-trauma, epilepsy, meningoencephalitis, psychosurgery, instable somatic conditions
- •risk of suicide or aggressive behaviour
- •history of electroconvulsive therapy, Parkinson's disease, Prolactin-dependent tumor
- •For the subset of subjects for the fMRI investigations the following additional exclusion criteria is valid as:
- •existence of metal in the body as by cardiac pacemaker, coil, total prosthesis, metal splinter, metal articulation, metal balls.
结局指标
主要结局
Clinical efficacy of both neuroleptics, especially with regard to cognitive deficits and functional brain activation between baseline and week 12
次要结局
- Change from baseline in PANSS negative symptom total score, PANSS subscores, CGI, CGI-severity of illness, HAMD, Simpson-Angus-Scale, BPRS, specific PANSS items , Startle reflex.
研究者
研究点 (1)
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