fMRI Study Comparing BOLD Activation Patterns Using GW679769 In Subjects With Social Anxiety Disorder
This study has been completed.
Information provided by:
First received: May 30, 2006
Last updated: October 15, 2008
Last verified: October 2008
Evidence suggests the use of neuroimaging to detect therapeutic effects of anxiolytic treatment when appropriate cognitive-emotional tasks are use to activate the emotional brain neurocircuitry believed to be involved in the core symptoms of the disease.
Social Anxiety Disorder
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Diagnostic
||A Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Parallel Group, fMRI Study Comparing BOLD Activation Patterns Before and After 12 Weeks of Treatment With Placebo, Comparator and GW679769 in Subjects With Social Anxiety Disorder (SAD).
Primary Outcome Measures:
- Change in images of the brain, when stimulated, after once daily dosing for 12 weeks with GW679769, comparator or placebo in subjects with SAD.
Secondary Outcome Measures:
- Blood levels of GW679769 and comparator at the Week 1 and Week 12 Change in clinical rating scales from baseline to Week 12 Safety & tolerability
| Estimated Enrollment:
| Study Start Date:
Other Name: GW679769
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Primary diagnosis of Social Anxiety Disorder.
- Willing to restrict alcohol to a limited intake.
- History of schizophrenia, schizoaffective disorder or a bipolar disorder.
- Suffer from claustrophobia.
- Any reason why subject could not go into the fMRI, for example have metal implants.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00332046
|GSK Investigational Site
|La Jolla, California, United States, 92093 |
||GSK Clinical Trials, MD
No publications provided
||Study Director, GSK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 30, 2006
||October 15, 2008
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
fMRI placebo GW679769 Social Anxiety Disorder SAD
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Neurokinin-1 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action