PharmacofMRI of Anxiolytic Medications (Pregabalin)

NCT ID: NCT00706836

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2008-12-31

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.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Pregabalin 50 mg

Pregabalin oral tablets (50 mg)

Group Type: ACTIVE_COMPARATOR

Pregabalin 50mg

Intervention Type: DRUG

One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan

Pregabalin 200 mg

Pregabalin oral tablets (200 mg)

Group Type: ACTIVE_COMPARATOR

Pregabalin 200 MG

Intervention Type: DRUG

One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

One dose of matched oral placebo to be administered one hour prior to fMRI scan

Interventions

Pregabalin 50mg

One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan

Intervention Type: DRUG

Pregabalin 200 MG

One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan

Intervention Type: DRUG

placebo

One dose of matched oral placebo to be administered one hour prior to fMRI scan

Intervention Type: DRUG

Other Intervention Names

Lyrica; Lyrica

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Murray B. Stein

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murray B Stein, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego

La Jolla, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21430645 (View on PubMed)

Other Identifiers

R01MH075792

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UCSD IRB 060407 - B

Identifier Type: -

Identifier Source: org_study_id