PharmacofMRI of Anxiolytic Medications (Pregabalin)

• 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: University of California, San Diego
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Murray B. Stein, University of California, San Diego

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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).

Contacts and Locations

Locations

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

• Principal Investigator: Murray B Stein, MD, MPH; University of California, San Diego

More Information

Publications of Results:

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.

• Responsible Party: Murray B. Stein, Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT00706836
• Other Study ID Numbers: UCSD IRB 060407 - B; R01MH075792 ( U.S. NIH Grant/Contract )
• First Posted: June 30, 2008
• 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:

Anxiety Disorders; Mental Disorders; Pregabalin; 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; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs