Drug Treatment Validation of Functional Magnetic Resonance Imaging in Generalized Anxiety Disorder
Recruitment status was Recruiting
The purpose of this study is to find out how an anti-anxiety drug or placebo affects the activity of your brain when you are at rest and when you are viewing emotional material, such as, emotional faces and pictures.
Generalized Anxiety Disorder
Drug: Alprazolam (Xanax)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized, Double-Blind, Placebo-Controlled Study of a Benzodiazepine vs Placebo on Functional Magnetic Resonance Imaging (fMRI) of the Brain, and on Behavioral/Clinical Measures in Patients With Generalized Anxiety Disorder|
- To evaluate the effect of an anxiolytic drug versus placebo on brain activity at rest and during emotional stimuli using fMRI. [ Time Frame: 7 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: 7 weeks ] [ Designated as safety issue: No ]
- To correlate the fMRI measurements with the clinical/behavioral measurements of efficacy. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder.
Drug: Alprazolam (Xanax)
Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks).
Other Name: Xanax
Placebo Comparator: placebo
A placebo comparator will be administered to 12 patients with generalized anxiety disorder
Placebo, bid, p.o. for 28 +/- 2 days.
This is an exploratory study to evaluate the usefulness of fMRI as a biomarker to measure the response to a known, FDA approved marketed anxiolytic. As such, this is not a study testing safety and efficacy of an approved medicine; it is a study to evaluate the usefulness of fMRI (a non-significant risk device procedure) to correlate the clinical/behavioral effects of a marketed anxiolytic with brain activity assessed by magnetic resonance imaging. fMRI is a more direct measure of brain function than behavior, outcomes are quantitative and objective. As such, it may be more specific, i.e., may be more sensitive to drug effects or show them earlier than clinical endpoints and enable determination of efficacy in smaller or shorter studies than those required to show effects on clinical endpoints. Finally, imaging may allow differentiation of placebo responders from true drug responders.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662259
|Contact: Elena Koshelevafirstname.lastname@example.org|
|United States, California|
|University of California, San Diego||Recruiting|
|San Diego, California, United States, 92093|
|Contact: Christina Wierenga, PhD 858-405-6677|
|Sub-Investigator: Gregory Brown, PhD|
|Principal Investigator:||Martin P Paulus, MD||University of California, San Diego|