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PharmacofMRI of Anxiolytic Medications (Pregabalin)

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pregabalin 50mg
Pregabalin 200 MG
placebo
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anxiety Disorders focused on measuring anxiety, functional magnetic resonance imaging, fMRI, pregabalin, Lyrica

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Pregabalin 50 mg

Pregabalin 200 mg

Placebo

Arm Description

Pregabalin oral tablets (50 mg)

Pregabalin oral tablets (200 mg)

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2008
Last Updated
April 2, 2019
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00706836
Brief Title
PharmacofMRI of Anxiolytic Medications (Pregabalin)
Official Title
PharmacofMRI of Anxiolytic Medications (Pregabalin)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
anxiety, functional magnetic resonance imaging, fMRI, pregabalin, Lyrica

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin 50 mg
Arm Type
Active Comparator
Arm Description
Pregabalin oral tablets (50 mg)
Arm Title
Pregabalin 200 mg
Arm Type
Active Comparator
Arm Description
Pregabalin oral tablets (200 mg)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Pregabalin 50mg
Other Intervention Name(s)
Lyrica
Intervention Description
One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan
Intervention Type
Drug
Intervention Name(s)
Pregabalin 200 MG
Other Intervention Name(s)
Lyrica
Intervention Description
One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
One dose of matched oral placebo to be administered one hour prior to fMRI scan
Primary Outcome Measure Information:
Title
Effect of Pregabalin (Two Doses) Versus Placebo
Description
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.
Time Frame
Week 1, 2, 3 (Cross-over Design)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murray B Stein, MD, MPH
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21430645
Citation
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.2011.32. Epub 2011 Mar 23.
Results Reference
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PharmacofMRI of Anxiolytic Medications (Pregabalin)

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