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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 0.25 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan. One-time, single dose. Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart. |
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| 2 | Active Comparator | 1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan One-time, single dose. Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart. |
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| Placebo | Placebo Comparator | Inactive ingredient in liquid matching appearance and volume of the two active alprazolam dose comparators. Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.25 mg alprazolam | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing | Analysis not completed. | Same Day |
| Voxelwise Brain Imaging Data | Analysis of data not completed. | Post-Rx Administration |
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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 |
|---|---|---|---|
| 19545475 | Background | Simmons AN, Arce E, Lovero KL, Stein MB, Paulus MP. Subchronic SSRI administration reduces insula response during affective anticipation in healthy volunteers. Int J Neuropsychopharmacol. 2009 Sep;12(8):1009-20. doi: 10.1017/S1461145709990149. Epub 2009 Jun 23. | |
| 21430645 | Background | 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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All subjects receive both doses of active drug and placebo in randomized order.
All subjects receive both doses of active drug and placebo in randomized order.
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| ID | Title | Description |
|---|---|---|
| FG000 | ALL SUBJECTS RECEIVE ALL 3 TREATMENTS | Alprazolam Low Dose Alprazolam High Dose Placebo Sequence of administration not available for subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing | Analysis not completed. | Posted | Same Day |
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Acute effects within 2 hours of drug administration
Acute, single-dose study
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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 | ALL SUBJECTS RECEIVE ALL 3 TREATMENTS | Alprazolam Low Dose Alprazolam High Dose Placebo |
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This is a single dose cross-over study in 16 healthy subjects.
BOLD fMRI analyses for this study were not completed by the investigators.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Murray B. Stein MD, MPH | UCSD | 858-534-6451 | mstein@ucsd.edu |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000525 | Alprazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 1.0 mg alprazolam | Drug | 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. |
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| placebo | Drug | 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. |
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| 22470326 | Background | Aupperle RL, Tankersley D, Ravindran LN, Flagan T, Stein NR, Stein MB, Paulus MP. Pregabalin effects on neural response to emotional faces. Front Hum Neurosci. 2012 Mar 27;6:42. doi: 10.3389/fnhum.2012.00042. eCollection 2012. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Voxelwise Brain Imaging Data | Analysis of data not completed. | Posted | Post-Rx Administration |
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| 0 |
| 16 |
| 0 |
| 16 |
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| D006571 | Heterocyclic Compounds |