Back to resultsfMRI Study Comparing BOLD Activation Patterns Using GW679769 In Subjects With Social Anxiety Disorder
Primary Purpose
Social Anxiety Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GW679769
Sponsored by
About this trial
This is an interventional diagnostic trial for Social Anxiety Disorder focused on measuring fMRI placebo GW679769 Social Anxiety Disorder SAD
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00332046
Brief Title
fMRI Study Comparing BOLD Activation Patterns Using GW679769 In Subjects With Social Anxiety Disorder
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 Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
fMRI placebo GW679769 Social Anxiety Disorder SAD
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
57 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GW679769
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Learn more about this trial
fMRI Study Comparing BOLD Activation Patterns Using GW679769 In Subjects With Social Anxiety Disorder
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