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The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in subjects with Social Anxiety Disorder
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paroxetine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Beverly Hills | California | 90210 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| NKF100110 | Informed Consent Form | View IPD |
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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 22, 2017 | |
| Unrelease | Yes | |
| Release | Jun 23, 2017 |
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| Burbank |
| California |
| 91506 |
| United States |
| GSK Investigational Site | Jacksonville | Florida | 32216 | United States |
| GSK Investigational Site | Miami | Florida | 33125 | United States |
| GSK Investigational Site | North Miami | Florida | 33161 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | Smyrna | Georgia | 30080 | United States |
| GSK Investigational Site | Oakbrook Terrace | Illinois | 60181 | United States |
| GSK Investigational Site | Rockville | Maryland | 20852 | United States |
| GSK Investigational Site | New York | New York | 10021 | United States |
| GSK Investigational Site | New York | New York | 10024 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19149 | United States |
| GSK Investigational Site | Lake Jackson | Texas | 77566 | United States |
| GSK Investigational Site | Buenos Aires | Buenos Aires | C1122AAN | Argentina |
| GSK Investigational Site | La Plata/Buenos Aires | Buenos Aires | B1896AEH | Argentina |
| GSK Investigational Site | Córdoba | Córdoba Province | 5000 | Argentina |
| GSK Investigational Site | Buenos Aires | C1062ABF | Argentina |
| GSK Investigational Site | Edmonton | Alberta | T6L 5X8 | Canada |
| GSK Investigational Site | Kelowna | British Columbia | V1Y 2H4 | Canada |
| GSK Investigational Site | Miramichi | New Brunswick | E1V 3G5 | Canada |
| GSK Investigational Site | Providencia / Santiago | Región Metro de Santiago | 7500710 | Chile |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 7580208 | Chile |
| GSK Investigational Site | San José | Provincia de San José | Costa Rica |
| GSK Investigational Site | San José | Costa Rica |
| GSK Investigational Site | Monterrey | Nuevo León | 64170 | Mexico |
| GSK Investigational Site | Mexico City | 03740 | Mexico |
For additional information about this study please refer to the GSK Clinical Study Register |
| NKF100110 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKF100110 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKF100110 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKF100110 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKF100110 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKF100110 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Reset | Jan 25, 2018 |
| Release | Mar 5, 2018 |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 22, 2017 | Yes | |||
| Jun 23, 2017 | Jan 25, 2018 | |||
| Mar 5, 2018 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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