PharmacofMRI of Anxiolytic Medications (Alprazolam)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing
研究概览
简要总结
The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy controls to examine the acute effects of certain anxiolytic medications on brain function.
详细描述
Increased amygdala and insula activity have been implicated in neurobiological models of anxiety. Using fMRI, the anxiolytic medication, lorazepam, has previously been found to decrease activation in these areas during the processing of emotional stimuli. This study aims to replicate those results but by using a different medication, alprazolam. An eventual aim of this study, in combination with future studies, is to evaluate the utility of fMRI as a tool to identify anxiolytic function in both established and novel compounds that may be used to treat anxiety.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male, or female (not pregnant or intending to become pregnant during the study)
- •Between the ages of 18-
- •In good general health.
- •No specific contraindications to the drug being administered
排除标准
- •Subjects with a history of DSM-IV depressive disorder, psychotic disorder, anxiety disorder
- •Subjects who meet criteria for substance abuse or dependence within the last 6 months
- •Subjects with an positive urine screen for illicit drugs
- •having clinically significant abnormal laboratory, ECG or physical examination findings not resolved by the baseline visit
- •Patients who have taken psychotropic drugs or antidepressants (including monoamine oxidase inhibitors, MAOI's) within the last year
- •subject is left-handed.
- •The subject suffers from claustrophobia, or phobia for injections or blood.
- •Magnetic Resonance Imaging related exclusion criteria: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), subjects who have ever been a metal worker/welder; history of eye surgery/eyes washed out because of metal, aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, subjects who are in the first trimester of pregnancy, subjects with an I.U.D. (birth control device), a shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit).
研究组 & 干预措施
1
0.25 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan.
One-time, single dose.
Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
干预措施: 0.25 mg alprazolam (Drug)
2
1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan
One-time, single dose.
Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
干预措施: 1.0 mg alprazolam (Drug)
Placebo
Inactive ingredient in liquid matching appearance and volume of the two active alprazolam dose comparators.
Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
干预措施: placebo (Drug)
结局指标
主要结局
Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing
时间窗: Same Day
Analysis not completed.
Voxelwise Brain Imaging Data
时间窗: Post-Rx Administration
Analysis of data not completed.
次要结局
未报告次要终点
研究者
Murray B. Stein
Professor
University of California, San Diego