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fMRI Study Comparing BOLD Activation Patterns Using GW679769 In Subjects With Social Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT00332046
Recruitment Status : Completed
First Posted : June 1, 2006
Last Update Posted : October 16, 2008
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: GW679769 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: 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).
Study Start Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Primary diagnosis of Social Anxiety Disorder.
  • Willing to restrict alcohol to a limited intake.

Exclusion criteria:

  • History of schizophrenia, schizoaffective disorder or a bipolar disorder.
  • Left-handed.
  • Suffer from claustrophobia.
  • Any reason why subject could not go into the fMRI, for example have metal implants.

Information from the National Library of Medicine

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): NCT00332046

United States, California
GSK Investigational Site
La Jolla, California, United States, 92093
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00332046     History of Changes
Other Study ID Numbers: NKF10015
First Posted: June 1, 2006    Key Record Dates
Last Update Posted: October 16, 2008
Last Verified: October 2008

Keywords provided by GlaxoSmithKline:
fMRI placebo GW679769 Social Anxiety Disorder SAD

Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action