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

Phase 1CompletedNCT00332046

GlaxoSmithKline57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Social Anxiety Disorder

Interventions

GW679769DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

La Jolla, California, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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