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).
| 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 |
| Verified date | October 2008 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| 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. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| United States | GSK Investigational Site | La Jolla | California |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States,
| 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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