PharmacofMRI of Anxiolytic Medications (Pregabalin)
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 Pregabalin (Two Doses) Versus Placebo
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. In this case, the medication pregabalin will be used. The investigators hypothesize that pregabalin (at doses of 50 mg and 200 mg, versus placebo) will yield a reduction in amygdala and insula activity (in a dose-dependent fashion) during emotion processing using fMRI.
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, pregabalin. 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
- •Subjects who are left-handed.
- •Subjects suffering 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
Placebo
Placebo
干预措施: placebo (Drug)
Pregabalin 50 mg
Pregabalin oral tablets (50 mg)
干预措施: Pregabalin 50mg (Drug)
Pregabalin 200 mg
Pregabalin oral tablets (200 mg)
干预措施: Pregabalin 200 MG (Drug)
结局指标
主要结局
Effect of Pregabalin (Two Doses) Versus Placebo
时间窗: Week 1, 2, 3 (Cross-over Design)
Region of Interest (ROI) analysis of contrast of doses (high and low) of pregabalin vs placebo on brain activity at rest and during emotional stimuli using fMRI and clinical scales.
次要结局
未报告次要终点
研究者
Murray B. Stein
Professor
University of California, San Diego