NCT01749098已完成1 期
A Randomized, Subject And Investigator Blinded, Sponsor Open Placebo Controlled, 2 Way, Crossover Phase 1b Study To Examine The Effects Of PF-04958242 On Ketamine Induced Cognitive Impairment In Healthy Male Volunteers
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
- Biogen
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Test score on the Hopkins Verbal Learning Test - Immediate Recall
研究概览
简要总结
To assess if PF-04958242 can attenuate the ketamine-induced cognitive impairment in verbal learning and memory, episodic memory and spatial working memory in healthy volunteers.
详细描述
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects 21 - 45 years old.
- •Able to read and write English as primary language.
- •Subjects who are willing to comply with study procedures.
排除标准
- •History of any substance abuse or dependence disorder meeting DSM-IV criteria and/or by SCID-NP within the past 12 months, with the exception of nicotine.
- •Known sensitivity to ketamine
- •Any history of DSM-IV Axis I psychiatric disorders, determined by SCID-NP interview or diagnoses in the view of the investigator.
研究组 & 干预措施
PF-04958242
Experimental
PF-04958242 and ketamine
干预措施: PF-04958242 (Drug)
PF-04958242
Experimental
PF-04958242 and ketamine
干预措施: Ketamine (Drug)
Placebo
Placebo Comparator
Placebo and ketamine
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Placebo and ketamine
干预措施: Ketamine (Drug)
结局指标
主要结局
Test score on the Hopkins Verbal Learning Test - Immediate Recall
时间窗: Day 5
次要结局
- Test score on the Weschler Digit Span Test(Day 5)
- Test score on the CogState N-back test(Day 5)
- Test score on the CogState Spatial Working memory test(Day 5)
- Test score on the CogState One Card Learning test(Day 5)
- Test score on the Hopkins Verbal Learning test - Delayed Recall(Day 5)
- Retrospective rating on the Positive and Negative Syndrome Scale -modified scale'(Day 5)
研究者
研究点 (1)
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