PharmacofMRI of Anxiolytic Medications (Pregabalin)

University of California, San Diego16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Anxiety Disorders

Interventions

Pregabalin 50mgDRUG

One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan

Pregabalin 200 MGDRUG

One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan

placeboDRUG

One dose of matched oral placebo to be administered one hour prior to fMRI scan

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

University of California, San Diego

La Jolla, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Week 1, 2, 3 (Cross-over Design)

Data from ClinicalTrials.gov

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