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Sponsors and Collaborators: |
University of California, San Diego Hoffmann-La Roche |
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Information provided by: | University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT00662259 |
The purpose of this study is to find out how an anti-anxiety drug or placebo affect the activity of your brain when you are at rest and when you are viewing emotional material, such as, emotional faces and pictures.
Condition | Intervention | Phase |
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Generalized Anxiety Disorder |
Drug: alprazolam Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment |
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 |
Estimated Enrollment: | 36 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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alprazolam: Experimental
Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder.
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Drug: alprazolam
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).
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placebo: Placebo Comparator
A placebo comparator will be administered to 12 patients with generalized anxiety disorder
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Drug: Placebo
bid, p.o. for 28 +/- 2 days
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Prior medications washout:
Exclusion Criteria:
Axis I disorder other than stated above with the exception of the following permitted comorbidities:
Contact: Christina Wierenga, PhD | 858-405-6677 |
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 |
Responsible Party: | University of California San Diego, Department of Psychiatry ( Martin P. Paulus, MD ) |
Study ID Numbers: | WP21030 |
Study First Received: | April 17, 2008 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00662259 |
Health Authority: | United States: Institutional Review Board |
Anxiety disorders Generalized anxiety |
Alprazolam Anxiety Disorders Mental Disorders |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Pharmacologic Actions Pathologic Processes Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Central Nervous System Agents |