PharmacofMRI of Anxiolytic Medications (Pregabalin)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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PharmacofMRI of Anxiolytic Medications (Pregabalin)

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Drug: Pregabalin 50mg
* Drug: Pregabalin 200 MG
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male, or female (not pregnant or intending to become pregnant during the study) Between the ages of 18-30. In good general health. No specific contraindications to the drug being administered Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pregabalin 50 mg<br>Pregabalin oral tablets (50 mg) | Drug: Pregabalin 50mg<br>* One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan<br>* Other names: Lyrica;|
| Active Comparator: Pregabalin 200 mg<br>Pregabalin oral tablets (200 mg) | Drug: Pregabalin 200 MG<br>* One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan<br>* Other names: Lyrica;|
| Placebo Comparator: Placebo<br>Placebo | Drug: placebo<br>* One dose of matched oral placebo to be administered one hour prior to fMRI scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Pregabalin (Two Doses) Versus Placebo | 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. | Week 1, 2, 3 (Cross-over Design) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, functional magnetic resonance imaging, fMRI, pregabalin, Lyrica