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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) 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, fatigue and pain;incidence of adverse events over course of 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 | Peoria | Arizona | 85381 - 4828 | United States | ||
| GSK Investigational Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 19, 2017 | |
| Reset | Nov 13, 2017 | |
| Release | Nov 20, 2017 |
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| Scottsdale |
| Arizona |
| 85251 |
| United States |
| GSK Investigational Site | Garden Grove | California | 92845 | United States |
| GSK Investigational Site | Irvine | California | 92618 | United States |
| GSK Investigational Site | National City | California | 91950 | United States |
| GSK Investigational Site | Miami | Florida | 33173 | United States |
| GSK Investigational Site | Winter Park | Florida | 32789 | United States |
| GSK Investigational Site | Springfield | Illinois | 62702 | United States |
| GSK Investigational Site | Terre Haute | Indiana | 47802 | United States |
| GSK Investigational Site | Florence | Kentucky | 41042 | United States |
| GSK Investigational Site | Brockton | Massachusetts | 2301 | United States |
| GSK Investigational Site | New York | New York | 10021 | United States |
| GSK Investigational Site | Chapel Hill | North Carolina | 27514 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | United States |
| GSK Investigational Site | Lyndhurst | Ohio | 44124 | United States |
| GSK Investigational Site | Eugene | Oregon | 97401 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19106 | United States |
| GSK Investigational Site | Austin | Texas | 78756 | United States |
| GSK Investigational Site | Galveston | Texas | 77555 | United States |
| GSK Investigational Site | Lake Jackson | Texas | 77566 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84107 | United States |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 19, 2017 | Nov 13, 2017 | |||
| Nov 20, 2017 | Aug 15, 2018 |
| 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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