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fMRI 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
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 30, 2006
Last Updated
October 15, 2008
Sponsor
GlaxoSmithKline
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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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