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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
- Primary diagnosis of Social Anxiety Disorder.
- Willing to restrict alcohol to a limited intake.
- History of schizophrenia, schizoaffective disorder or a bipolar disorder.
- Left-handed.
Inclusion and exclusion 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
GSK Investigational Site
La Jolla, California, United States, 92093
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
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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