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A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radafaxine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score after 8 weeks of treatment | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the MADRS score at other timepoints; change in the Global Impression; percentage of remitters and responders based on the MADRS; change in anxiety, disability, motivation, energy, fatigue and pain; incidence of adverse events during the study |
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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 | Cerritos | California | 90703 | United States | ||
| GSK Investigational Site |
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| San Diego |
| California |
| 92108 |
| United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20037 | United States |
| GSK Investigational Site | Boynton Beach | Florida | 33437 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32216 | United States |
| GSK Investigational Site | Tampa | Florida | 33613 | United States |
| GSK Investigational Site | Marietta | Georgia | 30060 | United States |
| GSK Investigational Site | Libertyville | Illinois | 60048 | United States |
| GSK Investigational Site | Oakbrook Terrace | Illinois | 60181 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | United States |
| GSK Investigational Site | Lafayette | Indiana | 47905 | United States |
| GSK Investigational Site | Shreveport | Louisiana | 71101 | United States |
| GSK Investigational Site | Rockville | Maryland | 20852 | United States |
| GSK Investigational Site | Saint Charles | Missouri | 63301 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87108 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Toledo | Ohio | 43623 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38119 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229-3815 | United States |
| GSK Investigational Site | Bellevue | Washington | 98004 | United States |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C496215 | radafaxine |
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