NCT00986531已完成1 期
A Single Center, Double-Blind, Randomized, Placebo-Controlled, Two-Period Crossover Study to Access an Early Signal of Efficacy for Cognition and Negative Symptoms With AZD8529 in Patients With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Functional magnetic resonance imaging (fMRI)
研究概览
简要总结
The purpose of this study is to assess if AZD8529 improves performance on neurobehavioral probes of attention, working memory and affective reactivity in patients with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of schizophrenia or schizoaffective disorder
排除标准
- •ECT in the last 6 months
- •Substance abuse or dependence
- •History of claustrophobia
研究组 & 干预措施
1
Experimental
80 mg AZD8529
干预措施: AZD8529 (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo to match AZD8529 (Drug)
结局指标
主要结局
Functional magnetic resonance imaging (fMRI)
时间窗: 1 fMRI on Day 4; 1 fMRI on Day 21
Computerized neurocognitive tests
时间窗: 1 on Day -1; 1 on Day 1 and on Day 21
次要结局
- Positive and Negative Syndrome Scale (PANSS)(Day-1; Day 4; Day 17; Day 21)
- Electroencephalography (EEG)(Day 4; Day 21)
- Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs,(Labs at screening and on Days -1, 4, 17, 21, and 35; ECG at screening and Day 35; Physical Exam at screening and Day 35; Vital signs at screening and Days -1,4, 17, 21, and 35)
- Suicidality assessment, collection of adverse events(Suicidality assesment at screening; and Days -1, 4, 17, 21, and 35 Adverse events at screening, and Days -1,4,17,21, and 35)
研究者
研究点 (1)
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