PharmacofMRI of Anxiolytic Medications (Pregabalin)

Condition(s) targeted: Anxiety Disorders

Intervention: pregabalin (Drug); pregabalin (Drug); placebo (Drug)

Phase: Phase 4

Status: Recruiting

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

Overall contact:
Lakshmi Ravindran, MD, Phone: 858-534-7352, Email: lravindran@ucsd.edu

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. We 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: Diagnostic, Randomized, Single Blind (Subject), Crossover Assignment

Primary outcome: To evaluate the effect of an anxiolytic drug versus placebo on brain activity at rest and during emotional stimuli using fMRI and clinical scales.

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.

Detailed description: 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. Gender(s): Both.

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).

Lakshmi Ravindran, MD, Phone: 858-534-7352, Email: lravindran@ucsd.edu

University of California, San Diego, La Jolla, California 92037, United States; Recruiting
Lakshmi Ravindran, MD, Phone: 858-534-7352, Email: lravindran@ucsd.edu
Murray B Stein, MD, MPH, Principal Investigator
Martin Paulus, MD, Principal Investigator
Lakshmi Ravindran, MD, Sub-Investigator

Related publications:

Paulus MP, Feinstein JS, Castillo G, Simmons AN, Stein MB. Dose-dependent decrease of activation in bilateral amygdala and insula by lorazepam during emotion processing. Arch Gen Psychiatry. 2005 Mar;62(3):282-8.

Breiter HC, Etcoff NL, Whalen PJ, Kennedy WA, Rauch SL, Buckner RL, Strauss MM, Hyman SE, Rosen BR. Response and habituation of the human amygdala during visual processing of facial expression. Neuron. 1996 Nov;17(5):875-87.

Simmons A, Matthews SC, Stein MB, Paulus MP. Anticipation of emotionally aversive visual stimuli activates right insula. Neuroreport. 2004 Oct 5;15(14):2261-5.

Starting date: June 2008
Ending date: February 2009
Last updated: June 27, 2008