Social Anxiety DisorderPhase 1NCT00332046
fMRI Study Comparing BOLD Activation Patterns Using GW679769 In Subjects With Social Anxiety Disorder
A Phase 1 study testing GW679769 in people with Social Anxiety Disorder, run by GlaxoSmithKline at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- GW679769
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary diagnosis of Social Anxiety Disorder.
- Willing to restrict alcohol to a limited intake.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
La Jolla, California, 92093
About this study
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).
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.
- Conditions
- Social Anxiety Disorder
- Being tested
- GW679769
- Keywords
- fMRI placebo GW679769 Social Anxiety Disorder SAD
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW679769Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2006 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 57 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332046
- Sponsor's protocol ID
- NKF10015
- Status last verified
- Oct 2008
- First submitted
- 30 May 2006
- Last updated
- 16 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00332046
- Acronym / sponsor ID
- NKF10015
- Conditions
- Social Anxiety Disorder
- Keywords
- fMRI placebo GW679769 Social Anxiety Disorder SAD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- First posted
- 1 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Primary diagnosis of Social Anxiety Disorder.
- Willing to restrict alcohol to a limited intake.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW679769 | Drug | – |
Primary outcome
Change in images of the brain, when stimulated, after once daily dosing for 12 weeks with GW679769, comparator or placebo in subjects with SAD.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, MD study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GW679769 in people with Social Anxiety Disorder, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in images of the brain, when stimulated, after once daily dosing for 12 weeks with GW679769, comparator or placebo in subjects with SAD.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2008.