Social Anxiety DisorderPhase 2NCT00273039
A Study Of A New Medicine (GW679769) For The Treatment Of Social Anxiety Disorder
A Phase 2 study testing paroxetine in people with Social Anxiety Disorder and Anxiety Disorders, run by GlaxoSmithKline at 27 sites in 6 countries.
Trial summary
The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in subjects with Social Anxiety Disorder Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder, Anxiety Disorders
- What is being tested?
- paroxetine
- How many people
- 242 participants
- Where
- 27 sitesin 6 countries
- Study dates
- Aug 2005to Sep 2006
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Generalized Social Anxiety Disorder as the primary diagnosis.
- If female, must commit to consistent and correct use of an acceptable method of birth control.
Who cannot join
- Patients with any other psychiatric disorder as a primary diagnosis or within 6 months prior to screening.
- Patients with Body Dysmophic Disorder, Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder.
- Patients who pose a current suicidal or homicidal risk or have made a suicide attempt within the past 6 months or have ever been homicidal.
- Patients who have a positive urine test at screen for illegal drug use and/or a history of substance abuse or dependence (alcohol or drugs) within the past 12 months.
- Patients with an unstable medical disorder.
- Female patients who are pregnant, lactating, or planning to become pregnant during a specified time during the study.
- Patients who are taking other psychoactive medications.
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
United States14 sites
GSK Investigational Site
Beverly Hills, California, 90210
GSK Investigational Site
Burbank, California, 91506
GSK Investigational Site
Jacksonville, Florida, 32216
GSK Investigational Site
Lake Jackson, Texas, 77566
GSK Investigational Site
Miami, Florida, 33125
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
New York, New York, 10024
GSK Investigational Site
North Miami, Florida, 33161
GSK Investigational Site
Oakbrook Terrace, Illinois, 60181
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
Philadelphia, Pennsylvania, 19149
GSK Investigational Site
Rockville, Maryland, 20852
GSK Investigational Site
Smyrna, Georgia, 30080
Argentina4 sites
GSK Investigational Site
Buenos Aires, Buenos Aires, C1122AAN
GSK Investigational Site
Buenos Aires, C1062ABF
GSK Investigational Site
Córdoba, Córdoba Province, 5000
GSK Investigational Site
La Plata/Buenos Aires, Buenos Aires, B1896AEH
Canada3 sites
GSK Investigational Site
Edmonton, Alberta, T6L 5X8
GSK Investigational Site
Kelowna, British Columbia, V1Y 2H4
GSK Investigational Site
Miramichi, New Brunswick, E1V 3G5
Chile2 sites
GSK Investigational Site
Providencia / Santiago, Región Metro de Santiago, 7500710
GSK Investigational Site
Santiago, Región Metro de Santiago, 7580208
Costa Rica2 sites
GSK Investigational Site
San José, Provincia de San José
GSK Investigational Site
San José
Mexico2 sites
GSK Investigational Site
Mexico City, 03740
GSK Investigational Site
Monterrey, Nuevo León, 64170
About this study
Official title: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects With Social Anxiety Disorder
The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in subjects with Social Anxiety Disorder
- Conditions
- Social Anxiety Disorder, Anxiety Disorders
- Being tested
- paroxetine
- Keywords
- Social Anxiety Disorder, Anxiety, Psychiatry
- Medical subject headings
- Phobia, Social, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paroxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS)
Secondary outcomes (1)
Secondary outcome measures include the change from baseline in the following scales: the Clinical Global Impression-Global Improvement, the Clinical Global Impression -Severity of Illness, and the Sheehan Disability Scale.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startAug 2005
- Primary completionSep 2006
- Study completionSep 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273039
- Sponsor's protocol ID
- NKF100110
- Status last verified
- Oct 2016
- First submitted
- 5 Jan 2006
- Last updated
- 26 Oct 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects With Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00273039
- Acronym / sponsor ID
- NKF100110
- Conditions
- Social Anxiety Disorder, Anxiety Disorders
- Keywords
- Social Anxiety Disorder, Anxiety, Psychiatry
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 9 Jan 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.
The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in subjects with Social Anxiety Disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Generalized Social Anxiety Disorder as the primary diagnosis.
- If female, must commit to consistent and correct use of an acceptable method of birth control.
Key exclusion criteria (7 listed)
- Patients with any other psychiatric disorder as a primary diagnosis or within 6 months prior to screening.
- Patients with Body Dysmophic Disorder, Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder.
- Patients who pose a current suicidal or homicidal risk or have made a suicide attempt within the past 6 months or have ever been homicidal.
- Patients who have a positive urine test at screen for illegal drug use and/or a history of substance abuse or dependence (alcohol or drugs) within the past 12 months.
- Patients with an unstable medical disorder.
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 |
|---|---|---|
| paroxetine | Drug | – |
Primary outcome
The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS)
1 secondary outcome
Secondary outcome measures include the change from baseline in the following scales: the Clinical Global Impression-Global Improvement, the Clinical Global Impression -Severity of Illness, and the Sheehan Disability Scale.
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 26 Oct 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 study director
GlaxoSmithKline
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paroxetine in people with Social Anxiety Disorder and Anxiety Disorders, run by GlaxoSmithKline at 27 sites in 6 countries.
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 7 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Argentina, Canada, Chile, Costa Rica and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS). 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 26 Oct 2016.