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Completed

NCT Number: NCT00706836

PharmacofMRI of Anxiolytic Medications (Pregabalin)

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Diego

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Pregabalin 50mg

Drug

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

Other names: Lyrica

Pregabalin 200 MG

Drug

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

Other names: Lyrica

Placebo

Drug

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

Primary outcomes

  1. Effect of Pregabalin (Two Doses) Versus Placebo

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 30, 2008
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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