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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH075792 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin 50 mg | Active Comparator | Pregabalin oral tablets (50 mg) |
|
| Pregabalin 200 mg | Active Comparator | Pregabalin oral tablets (200 mg) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin 50mg | Drug | One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 1, 2, 3 (Cross-over Design) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murray B Stein, MD, MPH | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21430645 | Result | 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. |
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Subjects determined to be healthy based on physical examination, mental health examination, and routine bloodwork.
Healthy subjects recruited by posted advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Pregabalin oral tablets (50 mg) Pregabalin oral tablets (200 mg) Placebo All participants received all 3 treatments on different days. Sequence not available. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
16 healthy subjects (10 male; mean age=23.2±2.6)
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| ID | Title | Description |
|---|---|---|
| BG000 | All 3 Treatments (Cross-Over Design) | Pregabalin oral tablets (50 mg) Pregabalin oral tables (200 mg) Placebo All subjects received all 3 treatments on different days. Sequence data not available. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Cross-over design, complete data available for all participants. Total number of participants in study is 16; all subjects received all 3 arms of treatment in randomized order. | Posted | Mean | Standard Error | % signal change L amygdala + anticipn | Week 1, 2, 3 (Cross-over Design) |
|
Acute within 2 hours of administration
Single dose acute adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin Low Dose (Crossover) | Pregabalin oral tablets (50 mg) pregabalin: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Non-systematic Assessment | Dizziness or lightheadedness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Murray B. Stein MD, MPH | University of California San Diego | 858-534-6400 | mstein@ucsd.edu |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Pregabalin 200 MG | Drug | One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan |
|
|
| placebo | Drug | One dose of matched oral placebo to be administered one hour prior to fMRI scan |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Pregabalin oral tablets (200 mg) pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan |
| OG002 | Placebo (Crossover) | Placebo placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Pregabalin High Dose (Crossover) | Pregabalin oral tablets (200 mg) pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan | 0 | 16 | 4 | 16 |
| EG002 | Placebo (Crossover) | Placebo placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan | 0 | 16 | 0 | 16 |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |