NCT00985933已完成早期 1 期
A Single Center, Double-Blind, Randomized, Double Dummy, Placebo-Controlled, Three-Period Crossover Study to Assess the Effects of a mGluR2/3 Positive Allosteric Modulator [AZD8529] Upon Ketamine-Induced Cortical Stimulation and Impairment of Working-Memory Related Activation of the Prefrontal Cortex
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- fMRI
研究概览
简要总结
The purpose of this study is to assess if ketamine will induce, in healthy volunteers, impairment of working memory and if the drug AZD8529 will block the effects of ketamine on working memory as assessed by functional magnetic resonance imaging (fMRI).
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
- 21 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Right handed
- •12th grade education or equivalent
- •Able to read and write English as primary language
排除标准
- •History of head injury
- •Substance abuse or dependence
- •History of claustrophobia
研究组 & 干预措施
2
Experimental
50 mg AD8529
干预措施: Placebo to match AZD8529 (Drug)
1
Experimental
180 mg of AZD8529
干预措施: Placebo to match AZD8529 (Drug)
3
Placebo Comparator
Placebo
干预措施: Placebo to match AZD8529 (Drug)
1
Experimental
180 mg of AZD8529
干预措施: AZD8529 (Drug)
2
Experimental
50 mg AD8529
干预措施: AZD8529 (Drug)
3
Placebo Comparator
Placebo
干预措施: AZD8529 (Drug)
结局指标
主要结局
fMRI
时间窗: 3
Ketamine Infusion
时间窗: 3
次要结局
- Clinician Administered Dissociative States Scale (CADSS)
- Positive and Negative Syndrome Scale (PANSS)
- Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs, collection of adverse events
研究者
研究点 (1)
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