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A placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of Seasonal Affective Disorder
A 7-Month Multicenter, Parallel, Double-Blind, Placebo-Controlled Comparison of 150-300mg/day of Extended-release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Depressive Episodes in Subjects with a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended-release Bupropion Hydrochloride | Other | Extended-release Bupropion Hydrochloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended-release Bupropion Hydrochloride | Drug | Bupropion hydrochloride will be available in dose strength of 150 and 300 milligram (mg). Subjects will receive one tablet of 150 mg bupropion hydrochloride from Day 1 to 7, from Day 8 to Week 27 will receive one tablet of 300 mg bupropion hydrochloride and from Week 28-29 one tablet of bupropion hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| End of season depression-free rate. | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of a seasonal depressive episode.Change from randomization on SIGH-SAD and HAMD-17. | 7 months |
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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 | Anchorage | Alaska | 99508 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Modell, JG, Rosenthal NE. Once-Daily Bupropion XL for the prevention of seasonal major depressive episodes. 43nd Annual Meeting of the American College of Neuropsychopharmacology, San Juan, Puerto Rico, 12-16 December, 2004. |
| Label | URL |
|---|---|
| Results for study 100006 can be found on the GSK Clinical Study Register. | View source |
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|
| Hamden |
| Connecticut |
| 06518 |
| United States |
| GSK Investigational Site | Newark | Delaware | 19713 | United States |
| GSK Investigational Site | Wilmington | Delaware | 19808 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20016 | United States |
| GSK Investigational Site | Boise | Idaho | 83702 | United States |
| GSK Investigational Site | Edwardsville | Illinois | 62025 | United States |
| GSK Investigational Site | Hoffman Estates | Illinois | 60194 | United States |
| GSK Investigational Site | Northfield | Illinois | 60093 | United States |
| GSK Investigational Site | Oak Brook | Illinois | 60523 | United States |
| GSK Investigational Site | Oakbrook Terrace | Illinois | 60181 | United States |
| GSK Investigational Site | Cedar Rapids | Iowa | 52401 | United States |
| GSK Investigational Site | Overland Park | Kansas | 66211 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21204 | United States |
| GSK Investigational Site | Rockville | Maryland | 20852 | United States |
| GSK Investigational Site | Belmont | Massachusetts | 02478 | United States |
| GSK Investigational Site | Farmington Hills | Michigan | 48334 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55454 | United States |
| GSK Investigational Site | St Louis | Missouri | 63108 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68198 | United States |
| GSK Investigational Site | Kenilworth | New Jersey | 07033 | United States |
| GSK Investigational Site | Moorestown | New Jersey | 08057 | United States |
| GSK Investigational Site | Piscataway | New Jersey | 08854 | United States |
| GSK Investigational Site | Princeton | New Jersey | 08540 | United States |
| GSK Investigational Site | Albany | New York | 12208 | United States |
| GSK Investigational Site | Lawrence | New York | 11559 | United States |
| GSK Investigational Site | New York | New York | 10021 | United States |
| GSK Investigational Site | New York | New York | 10032 | United States |
| GSK Investigational Site | New York | New York | 10128 | United States |
| GSK Investigational Site | Rochester | New York | 14618 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45219 | United States |
| GSK Investigational Site | Columbus | Ohio | 43210 | United States |
| GSK Investigational Site | Lyndhurst | Ohio | 44124 | United States |
| GSK Investigational Site | Toledo | Ohio | 43623 | United States |
| GSK Investigational Site | Eugene | Oregon | 97401 | United States |
| GSK Investigational Site | Portland | Oregon | 97201 | United States |
| GSK Investigational Site | Portland | Oregon | 97209 | United States |
| GSK Investigational Site | Portland | Oregon | 97210 | United States |
| GSK Investigational Site | Allentown | Pennsylvania | 18104 | United States |
| GSK Investigational Site | Havertown | Pennsylvania | 19083 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19106 | United States |
| GSK Investigational Site | Lincoln | Rhode Island | 02865-4208 | United States |
| GSK Investigational Site | Woodstock | Vermont | 05091 | United States |
| GSK Investigational Site | Spokane | Washington | 99204 | United States |
| GSK Investigational Site | Brown Deer | Wisconsin | 53223 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53719 | United States |
| GSK Investigational Site | Menomonee Falls | Wisconsin | 53051 | United States |
| GSK Investigational Site | Middleton | Wisconsin | 53562-2215 | United States |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D016574 | Seasonal Affective Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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