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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 March 30, 2015
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Peripheral Nervous System Agents
Physiological Effects of Drugs