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A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Radafaxine 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 Clinical Global Impression; percentage of remitters and responders based on the MADRS; change in disability, motivation, energy and pain;incidence of adverse events over course of study. | 8 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, M.D. | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Little Rock | Arkansas | 72223 | United States | ||
| GSK Investigational Site |
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| Newport Beach |
| California |
| 92660-2814 |
| United States |
| GSK Investigational Site | Farmington | Connecticut | 6708 | United States |
| GSK Investigational Site | Largo | Florida | 33773 | United States |
| GSK Investigational Site | Maitland | Florida | 32751 | United States |
| GSK Investigational Site | Miami | Florida | 33156 | United States |
| GSK Investigational Site | North Miami | Florida | 33161 | United States |
| GSK Investigational Site | Edwardsville | Illinois | 62025 | United States |
| GSK Investigational Site | Glen Burnie | Maryland | 21061 | United States |
| GSK Investigational Site | Farmington Hills | Michigan | 48336 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55454 | United States |
| GSK Investigational Site | Clementon | New Jersey | 08021 | United States |
| GSK Investigational Site | Kenilworth | New Jersey | 07033 | United States |
| GSK Investigational Site | Lawrence | New York | 11559 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28203 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44106 | United States |
| GSK Investigational Site | Dayton | Ohio | 45408 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73118 | United States |
| GSK Investigational Site | Eugene | Oregon | 97401 | United States |
| GSK Investigational Site | Portland | Oregon | 97209 | United States |
| GSK Investigational Site | Portland | Oregon | 97210 | United States |
| GSK Investigational Site | Conshohocken | Pennsylvania | 19428 | United States |
| GSK Investigational Site | Dallas | Texas | 75235 | United States |
| GSK Investigational Site | Houston | Texas | 77004 | United States |
| GSK Investigational Site | Irving | Texas | 75039 | United States |
| GSK Investigational Site | Woodstock | Vermont | 05091 | United States |
| GSK Investigational Site | Seattle | Washington | 98104 | United States |
| GSK Investigational Site | Tacoma | Washington | 98499 | United States |
| GSK Investigational Site | Brown Deer | Wisconsin | 53223 | 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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