Drug Treatment Validation of Functional Magnetic Resonance Imaging in Generalized Anxiety Disorder
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|ClinicalTrials.gov Identifier: NCT00662259|
Recruitment Status : Unknown
Verified May 2009 by University of California, San Diego.
Recruitment status was: Recruiting
First Posted : April 21, 2008
Last Update Posted : May 22, 2009
|Condition or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder||Drug: Alprazolam (Xanax) Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2009|
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.
- 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 ]
- 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 ]
- To correlate the fMRI measurements with the clinical/behavioral measurements of efficacy. [ Time Frame: 7 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|