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NCT00332046 Clinical Trial

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

Social Anxiety Disorder Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00332046
Other study ID # NKF10015
Secondary ID
Status Completed
Phase Phase 1
First received May 30, 2006
Last updated October 15, 2008
Start date January 2006

Study information
Verified date October 2008
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• GW679769

Locations
Country Name City State
United States GSK Investigational Site La Jolla California

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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