PharmacofMRI of Anxiolytic Medications (Pregabalin)

Phase 4

Completed

• Conditions: Anxiety Disorders
• Interventions: Drug: Pregabalin 50mg; Drug: Pregabalin 200 MG; Drug: placebo

• Registration Number: NCT00706836
• Lead Sponsor: University of California, San Diego

Brief 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.

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-06-30
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2014-12-03
• Results First Submitted QC: 2014-12-19
• Results First Posted: 2014-12-22
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pregabalin 50 mg	Pregabalin 50mg	Pregabalin oral tablets (50 mg)
Pregabalin 200 mg	Pregabalin 200 MG	Pregabalin oral tablets (200 mg)
Placebo	placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Effect of Pregabalin (Two Doses) Versus Placebo	Week 1, 2, 3 (Cross-over Design)	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.

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States