PharmacofMRI (Functional Magnetic Resonance Imaging) of Anxiolytic Medications (Alprazolam)
This study has been completed.
Sponsor:
University of California, San Diego
Collaborator:
Information provided by (Responsible Party):
Murray B. Stein, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00703885
First received: June 20, 2008
Last updated: December 28, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety Disorders |
Drug: alprazolam Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic |
| Official Title: | PharmacofMRI of Anxiolytic Medications (Alprazolam) |
Resource links provided by NLM:
Further study details as provided by University of California, San Diego:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 16 |
| Study Start Date: | January 2008 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Alprazolam 0.25 mg PO (liquid) will be administered 1 hour prior to fMRI scan
|
Drug: alprazolam
alprazolam 0.25 mg PO (liquid) to be administered 1 hour prior to fMRI scan
Other Name: Xanax
|
|
Active Comparator: 2
Alprazolam 1 mg PO (liquid) will be administered 1 hour prior to fMRI scan
|
Drug: alprazolam
Alprazolam 1 mg PO (liquid) will be administered 1 hour prior to fMRI scan
Other Name: Xanax
|
| Placebo Comparator: Placebo |
Drug: placebo
Placebo (liquid) to be administered 1 hour prior to fMRI scan
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703885
Locations
| United States, California | |
| University of California, San Diego | |
| La Jolla, California, United States, 92037 | |
Sponsors and Collaborators
University of California, San Diego
Investigators
| Principal Investigator: | Murray B Stein, MD, MPH | University of California, San Diego |
More Information
No publications provided
| Responsible Party: | Murray B. Stein, Professor, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT00703885 History of Changes |
| Other Study ID Numbers: | UCSD IRB 060407 - A |
| Study First Received: | June 20, 2008 |
| Last Updated: | December 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Diego:
|
functional magnetic resonance imaging fMRI alprazolam anxiety disorders |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Alprazolam Anti-Anxiety Agents Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013