| June 20, 2008 |
| September 15, 2008 |
| January 2008 |
| August 2008 (final data collection date for primary outcome measure) |
| To evaluate the effect of an anxiolytic drug versus placebo on brain activity at rest and during emotional stimuli using fMRI [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] |
| To evaluate the effect of an anxiolytic drug versus placebo on brain activity at rest and during emotional stimuli using fMRI. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] |
| Complete list of historical versions of study NCT00703885 on ClinicalTrials.gov Archive Site |
| To evaluate the effects of an anxiolytic drug versus placebo on eye blink startle response at rest and during emotional stimuli (anxiety potentiated startle, APS) as well as on clinical scales [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] |
| To evaluate the effects of an anxiolytic drug versus placebo on eye blink startle response at rest and during emotional stimuli (anxiety potentiated startle, APS) as well as on clinical scales. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] |
| |
| PharmacofMRI (Functional Magnetic Resonance Imaging) of Anxiolytic Medications (Alprazolam) |
| PharmacofMRI of Anxiolytic Medications (Alprazolam) |
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. |
| Phase IV |
| Interventional |
| Diagnostic, Randomized, Single Blind (Subject), Crossover Assignment |
| Anxiety Disorders |
- Drug: alprazolam
- Drug: placebo
|
- Active Comparator: Alprazolam 0.25 mg PO (liquid) will be administered 1 hour prior to fMRI scan
- Active Comparator: Alprazolam 1 mg PO (liquid) will be administered 1 hour prior to fMRI scan
|
- Paulus MP, Feinstein JS, Castillo G, Simmons AN, Stein MB. Dose-dependent decrease of activation in bilateral amygdala and insula by lorazepam during emotion processing. Arch Gen Psychiatry. 2005 Mar;62(3):282-8.
- Breiter HC, Etcoff NL, Whalen PJ, Kennedy WA, Rauch SL, Buckner RL, Strauss MM, Hyman SE, Rosen BR. Response and habituation of the human amygdala during visual processing of facial expression. Neuron. 1996 Nov;17(5):875-87.
- Simmons A, Matthews SC, Stein MB, Paulus MP. Anticipation of emotionally aversive visual stimuli activates right insula. Neuroreport. 2004 Oct 5;15(14):2261-5.
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| |
| Completed |
| 16 |
| August 2008 |
| August 2008 (final data collection date for primary outcome measure) |
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 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).
|
| Both |
| 18 Years to 30 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00703885 |
| Murray B. Stein, University of California, San Diego |
| UCSD IRB 060407 - A |
| University of California, San Diego |
| National Institute of Mental Health (NIMH) |
| Principal Investigator: |
Murray B Stein, MD, MPH |
University of California, San Diego |
|
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| University of California, San Diego |
| June 2008 |
