Anxiety Disorders
Conditions
Keywords
anxiety, functional magnetic resonance imaging, fMRI, pregabalin, Lyrica
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.
Interventions
DRUGPregabalin 50mg
One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan
DRUGPregabalin 200 MG
One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan
DRUGplacebo
One dose of matched oral placebo to be administered one hour prior to fMRI scan
Sponsors
National Institute of Mental Health (NIMH)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Pregabalin (Two Doses) Versus Placebo | 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. |
Countries
United States
Participant flow
Recruitment details
Healthy subjects recruited by posted advertisements.
Pre-assignment details
Subjects determined to be healthy based on physical examination, mental health examination, and routine bloodwork.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | All 3 Treatments (Cross-Over Design) |
|---|---|
| Age, Continuous | 23.2 years STANDARD_DEVIATION 2.6 |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 4 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
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.
Time frame: Week 1, 2, 3 (Cross-over Design)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin Low Dose (Crossover) | Effect of Pregabalin (Two Doses) Versus Placebo | 0.6 % signal change L amygdala + anticipn | Standard Error 0.2 |
| Pregabalin High Dose (Crossover) | Effect of Pregabalin (Two Doses) Versus Placebo | -0.1 % signal change L amygdala + anticipn | Standard Error 0.1 |
| Placebo (Crossover) | Effect of Pregabalin (Two Doses) Versus Placebo | 0.6 % signal change L amygdala + anticipn | Standard Error 0.2 |