NCT00332046

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2006

Completed
Last Updated

October 16, 2008

Status Verified

October 1, 2008

First QC Date

May 30, 2006

Last Update Submit

October 15, 2008

Conditions

Social Anxiety Disorder

Keywords

fMRI placebo GW679769 Social Anxiety Disorder SAD

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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

Interventions

GW679769DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primary diagnosis of Social Anxiety Disorder.
  • Willing to restrict alcohol to a limited intake.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

casopitant

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2006

First Posted

June 1, 2006

Study Start

January 1, 2006

Last Updated

October 16, 2008

Record last verified: 2008-10

Locations

US(1)