PharmacofMRI of Anxiolytic Medications (Pregabalin)

Anxiety Disorders Clinical Trial

Official title:

PharmacofMRI of Anxiolytic Medications (Pregabalin)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706836
• Other study ID #: UCSD IRB 060407 - B
• Secondary ID: R01MH075792
• Status: Completed
• Phase: Phase 4
• Start date: June 2008
• Est. completion date: December 2008

Study information

• Verified date: April 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Drug:
• Pregabalin 50mg
One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan
• Pregabalin 200 MG
One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan
• placebo
One dose of matched oral placebo to be administered one hour prior to fMRI scan

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Aupperle RL, Ravindran L, Tankersley D, Flagan T, Stein NR, Simmons AN, Stein MB, Paulus MP. Pregabalin influences insula and amygdala activation during anticipation of emotional images. Neuropsychopharmacology. 2011 Jun;36(7):1466-77. doi: 10.1038/npp.20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Pregabalin (Two Doses) Versus Placebo	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.	Week 1, 2, 3 (Cross-over Design)