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PharmacofMRI of Anxiolytic Medications (Pregabalin)

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ClinicalTrials.gov Identifier: NCT00706836
Recruitment Status : Completed
First Posted : June 30, 2008
Results First Posted : December 22, 2014
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Murray B. Stein, 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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Drug: Pregabalin 50mg Drug: Pregabalin 200 MG Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: PharmacofMRI of Anxiolytic Medications (Pregabalin)
Study Start Date : June 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Pregabalin

Arm Intervention/treatment
Active Comparator: Pregabalin 50 mg
Pregabalin oral tablets (50 mg)
Drug: Pregabalin 50mg
One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan
Other Name: Lyrica

Active Comparator: Pregabalin 200 mg
Pregabalin oral tablets (200 mg)
Drug: Pregabalin 200 MG
One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan
Other Name: Lyrica

Placebo Comparator: Placebo
Placebo
Drug: placebo
One dose of matched oral placebo to be administered one hour prior to fMRI scan




Primary Outcome Measures :
  1. Effect of Pregabalin (Two Doses) Versus Placebo [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706836


Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Murray B Stein, MD, MPH University of California, San Diego

Publications of Results:
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Responsible Party: Murray B. Stein, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00706836     History of Changes
Other Study ID Numbers: UCSD IRB 060407 - B
R01MH075792 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2008    Key Record Dates
Results First Posted: December 22, 2014
Last Update Posted: April 9, 2019
Last Verified: April 2019

Keywords provided by Murray B. Stein, University of California, San Diego:
anxiety
functional magnetic resonance imaging
fMRI
pregabalin
Lyrica

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Pregabalin
Anti-Anxiety Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs