Last updated: 11/04/2018 09:42:08

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

GSK study ID
NKF10015
Clinicaltrials.gov ID
NCT00332046
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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).
Trial description: 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.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: GW679769
    • Enrollment:
    57
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Social Anxiety Disorder
    Product
    casopitant, paroxetine
    Collaborators
    Not applicable
    Study date(s)
    January 2006 to January 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 50 Years
    Accepts healthy volunteers
    no
    • Inclusion criteria:
    • Primary diagnosis of Social Anxiety Disorder.
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    La Jolla, California, United States, 92093
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-09-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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