Anxiety Disorders
Conditions
Keywords
functional magnetic resonance imaging, fMRI, alprazolam, anxiety disorders
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.
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, alprazolam. 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
DRUG0.25 mg alprazolam
0.25 mg alprazolam PO (liquid) to be administered 1 hour prior to fMRI scan Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
DRUG1.0 mg alprazolam
1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
DRUGplacebo
Placebo (liquid) to be administered 1 hour prior to fMRI scan Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
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 * subject is left-handed. * The subject suffers from claustrophobia, or phobia for injections or blood. * Magnetic Resonance Imaging related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing | Same Day | Analysis not completed. |
| Voxelwise Brain Imaging Data | Post-Rx Administration | Analysis of data not completed. |
Countries
United States
Participant flow
Recruitment details
All subjects receive both doses of active drug and placebo in randomized order.
Pre-assignment details
All subjects receive both doses of active drug and placebo in randomized order.
Participants by arm
| Arm | Count |
|---|---|
| ALL SUBJECTS RECEIVE ALL 3 TREATMENTS Alprazolam Low Dose Alprazolam High Dose Placebo
Please note that this is a cross-over design with all subjects receiving all three treatments | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | ALL SUBJECTS RECEIVE ALL 3 TREATMENTS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| 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 |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing
Analysis not completed.
Time frame: Same Day
Primary
Voxelwise Brain Imaging Data
Analysis of data not completed.
Time frame: Post-Rx Administration