PharmacofMRI of Anxiolytic Medications (Pregabalin)
Information source: University of California, San Diego
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anxiety Disorders
Intervention: pregabalin (Drug); pregabalin (Drug); placebo (Drug)
Phase: Phase 4
Sponsored by: University of California, San Diego
Official(s) and/or principal investigator(s):
Murray B Stein, MD, MPH, Principal Investigator, Affiliation: University of California, San Diego
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.
Official title: PharmacofMRI of Anxiolytic Medications (Pregabalin)
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Primary outcome: Effect of Pregabalin (Two Doses) Versus Placebo
Secondary outcome: To Evaluate the Effects of an Anxiolytic Drug Versus Placebo on Eye Blink Startle Response at Rest and During Emotional Stimuli (Anxiety Potentiated Startle, APS) as Well as on Clinical Scales.
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.
Minimum age: 18 Years.
Maximum age: 30 Years.
- 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
- Subjects with a history of DSM-IV depressive disorder, psychotic disorder, anxiety
- 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 and Contacts
University of California, San Diego, La Jolla, California 92037, United States
Starting date: June 2008
Last updated: December 19, 2014