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This is a placebo-controlled, fixed dose study that will evaluate the efficacy and safety of GW679769 in subjects with major depressive disorder.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW679769 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on the 17-item Hamilton Depression Rating Scale (HAM-D) total score at week 8, Last Observation Carried Forward. |
| Measure | Description | Time Frame |
|---|---|---|
| CGI, HAM-A, QUIDS, SDS, MOS-12 Sleep Module, LSEQ, Safety and Tolerability, PK/PD |
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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 | Scottsdale | Arizona | 85251 | United States | ||
| GSK Investigational Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 7, 2017 | |
| Reset | Apr 17, 2017 | |
| Release | Sep 1, 2017 |
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| Little Rock |
| Arkansas |
| 72223 |
| United States |
| GSK Investigational Site | Beverly Hills | California | 90210 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33301 | 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 | Winter Park | Florida | 32789 | United States |
| GSK Investigational Site | Marietta | Georgia | 30060 | United States |
| GSK Investigational Site | Smyrna | Georgia | 30080 | United States |
| GSK Investigational Site | Oakbrook Terrace | Illinois | 60181 | United States |
| GSK Investigational Site | Shreveport | Louisiana | 71104 | United States |
| GSK Investigational Site | Rockville | Maryland | 20852 | United States |
| GSK Investigational Site | Farmington Hills | Michigan | 48336 | United States |
| GSK Investigational Site | Saint Charles | Missouri | 63301 | United States |
| GSK Investigational Site | Clementon | New Jersey | 08021 | United States |
| GSK Investigational Site | Brooklyn | New York | 11235 | 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 | Beachwood | Ohio | 44122 | United States |
| GSK Investigational Site | Eugene | Oregon | 97401 | United States |
| GSK Investigational Site | Portland | Oregon | 97209 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38119 | United States |
| GSK Investigational Site | Austin | Texas | 78756 | United States |
| GSK Investigational Site | Irving | Texas | 75039 | United States |
| GSK Investigational Site | Lake Jackson | Texas | 77566 | United States |
| GSK Investigational Site | Bellevue | Washington | 98004 | United States |
| GSK Investigational Site | Edmonton | Alberta | T6L 5X8 | Canada |
| GSK Investigational Site | Miramichi | New Brunswick | E1V 3G5 | Canada |
| GSK Investigational Site | Mississauga | Ontario | L5M 4N4 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 4J6 | Canada |
| Reset | Mar 30, 2018 |
| Release | Apr 2, 2018 |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 7, 2017 | Apr 17, 2017 | |||
| Sep 1, 2017 | Mar 30, 2018 | |||
| Apr 2, 2018 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C531951 | casopitant |
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