NCT01045083已完成1 期
Randomized, Observer-blind, Placebo-controlled, Four-way Cross-over Study to Study the Ability of Functional Magnetic Resonance Imaging (fMRI) of the Brain to Detect and Characterize the Effects of Single Doses of a Selective Serotonin Reuptake Inhibitor (Escitalopram [Lexapro]), a Dopamine
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- To evaluate the ability of fMRI to detect and characterize the effect of the three drugs on brain activity at rest and during emotional stimuli
研究概览
简要总结
This is an exploratory study to evaluate the usefulness of fMRI as a biomarker to characterize the response to three centrally active drugs and placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients, 18 to 45 years of age
- •In good general health
- •Weight of ≥120 lbs (55 kg) and a body mass index (BMI) between 18 to 30kg/m²
- •Males and females with reproductive potential: willing to use a reliable method of contraception
排除标准
- •Evidence of clinically significant disease
- •Medical or surgical condition that could alter the absorption, metabolism, or elimination of drugs
- •Family history of sudden death or ventricular arrhythmia
- •History of any psychiatric disorder and/or marked anxiety
- •History of glaucoma
- •History (including family) of motor tic or diagnosis of Tourette's syndrome
- •Active suicide ideation
- •Contraindication to MRI
研究组 & 干预措施
1
Experimental
干预措施: RO4917523 (Drug)
1
Experimental
干预措施: escitalopram (Drug)
1
Experimental
干预措施: methylphenidate (Drug)
1
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
To evaluate the ability of fMRI to detect and characterize the effect of the three drugs on brain activity at rest and during emotional stimuli
时间窗: 8 weeks
次要结局
- To evaluate the ability of other behavioural paradigms/scales to detect drug effects(8 weeks)
- To correlate the fMRI measures with the clinical/behavioral measures(8 weeks)
- To investigate the safety of single doses of RO4917523 in healthy volunteers(8 weeks)
研究者
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