PharmacofMRI of Anxiolytic Medications (Pregabalin)

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Anti-Anxiety Agents; Pregabalin

Criteria

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).