跳至主要内容
临床试验/NCT00985933
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

AstraZeneca1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年2月最近更新:
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

发起方
AstraZeneca
申办方类型
Industry

研究点 (1)

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