PharmacofMRI of Anxiolytic Medications (Pregabalin) - Full Text View

Sponsors and Collaborators:	University of California, San Diego National Institute of Mental Health (NIMH)
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00706836

Purpose

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.

Condition	Intervention	Phase
Anxiety Disorders	Drug: pregabalin Drug: placebo	Phase IV

MedlinePlus related topics: Anxiety MRI Scans

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Subject), Crossover Assignment
Official Title:	PharmacofMRI of Anxiolytic Medications (Pregabalin)

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

To evaluate the effect of an anxiolytic drug versus placebo on brain activity at rest and during emotional stimuli using fMRI and clinical scales. [ Time Frame: Week 1, 2, 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: Week 1, 2, 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	June 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Pregabalin oral tablets (50 mg)	Drug: pregabalin One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan
2: Active Comparator Pregabalin oral tablets (200 mg)	Drug: pregabalin One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan
3: Placebo Comparator	Drug: placebo One dose of matched oral placebo to be administered one hour prior to fMRI scan

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.

Eligibility

Ages Eligible for Study:	18 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706836

Contacts

Contact: Lakshmi Ravindran, MD	858-534-7352	lravindran@ucsd.edu
Contact: Murray B Stein, MD,MPH		mstein@ucsd.edu

Locations

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

Sponsors and Collaborators

University of California, San Diego

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Murray B Stein, MD, MPH

University of California, San Diego

More Information

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.

Responsible Party:	University of California, San Diego ( Murray B. Stein )
Study ID Numbers:	UCSD IRB 060407 - B
Study First Received:	June 26, 2008
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00706836
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:

anxiety
functional magnetic resonance imaging
fMRI
pregabalin
Lyrica

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Pregabalin

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009