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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00093288 |
Purpose
This is a placebo-controlled study evaluating the effectiveness of medication in elderly subjects with Major Depressive Disorder (MDD).
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder (MDD) |
Drug: bupropion XL |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible Dose Study to Evaluate the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg-300mg Once Daily) in Elderly Subjects With Major Depressive Disorder |
| Estimated Enrollment: | 364 |
| Study Start Date: | June 2004 |
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, California | |
| GSK Investigational Site | |
| San Marino, California, United States, 91108 | |
| GSK Investigational Site | |
| Temecula, California, United States, 92591 | |
| GSK Investigational Site | |
| Oceanside, California, United States, 92056 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Colorado Springs, Colorado, United States, 80904 | |
| United States, Connecticut | |
| GSK Investigational Site | |
| Norwich, Connecticut, United States, 06360 | |
| United States, Florida | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32806 | |
| GSK Investigational Site | |
| Sarasota, Florida, United States, 34232 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33125 | |
| GSK Investigational Site | |
| Hialeah, Florida, United States, 33016 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Oak Brook, Illinois, United States, 60523 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| Shreveport, Louisiana, United States, 71101 | |
| United States, Maryland | |
| GSK Investigational Site | |
| Rockville, Maryland, United States, 20852 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Kenilworth, New Jersey, United States, 07033 | |
| GSK Investigational Site | |
| Princeton, New Jersey, United States, 08540 | |
| GSK Investigational Site | |
| Clementon, New Jersey, United States, 08021 | |
| United States, New York | |
| GSK Investigational Site | |
| Staten Island, New York, United States, 10305 | |
| GSK Investigational Site | |
| New York, New York, United States, 10021 | |
| GSK Investigational Site | |
| Brooklyn, New York, United States, 11235 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73118 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| GSK Investigational Site | |
| Austin, Texas, United States, 78756 | |
| GSK Investigational Site | |
| Richardson, Texas, United States, 75080 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| Australia, Queensland | |
| GSK Investigational Site | |
| New Farm, Queensland, Australia, 4005 | |
| GSK Investigational Site | |
| Everton Park, Queensland, Australia, 4053 | |
| GSK Investigational Site | |
| Caboolture, Queensland, Australia, 4510 | |
| Australia, Victoria | |
| GSK Investigational Site | |
| Malvern, Melbourne, Victoria, Australia, 3144 | |
| GSK Investigational Site | |
| St. Albans, Victoria, Australia, 3021 | |
| GSK Investigational Site | |
| Heidelberg West, Victoria, Australia, 3081 | |
| GSK Investigational Site | |
| Melbourne, Victoria, Australia, 3076 | |
| Belgium | |
| GSK Investigational Site | |
| Mont-Godinne, Belgium, 5530 | |
| GSK Investigational Site | |
| Montignies-sur-Sambre, Belgium, 6061 | |
| GSK Investigational Site | |
| Liège, Belgium, 4000 | |
| Canada, British Columbia | |
| GSK Investigational Site | |
| Kelowna, British Columbia, Canada, V1Y 2H4 | |
| Canada, Nova Scotia | |
| GSK Investigational Site | |
| Sydney, Nova Scotia, Canada, B1P 1C6 | |
| Canada, Ontario | |
| GSK Investigational Site | |
| Chatham, Ontario, Canada, N7L 1B7 | |
| GSK Investigational Site | |
| Mississauga, Ontario, Canada, L5M 4N4 | |
| Croatia | |
| GSK Investigational Site | |
| Zagreb, Croatia, 10000 | |
| GSK Investigational Site | |
| Osijek, Croatia | |
| Finland | |
| GSK Investigational Site | |
| Pori, Finland, 28100 | |
| GSK Investigational Site | |
| Kuopio, Finland, 70110 | |
| GSK Investigational Site | |
| Turku, Finland, 20100 | |
| GSK Investigational Site | |
| Mikkeli, Finland, 50100 | |
| GSK Investigational Site | |
| Espoo, Finland, 02650 | |
| France | |
| GSK Investigational Site | |
| Strasbourg, France, 67100 | |
| GSK Investigational Site | |
| Nimes, France, 30900 | |
| GSK Investigational Site | |
| Le Pecq, France, 78230 | |
| GSK Investigational Site | |
| Cherbourg, France, 50100 | |
| GSK Investigational Site | |
| Chatou, France, 78400 | |
| GSK Investigational Site | |
| Chateau Gontier, France, 53200 | |
| GSK Investigational Site | |
| Toulouse, France, 31000 | |
| GSK Investigational Site | |
| Orvault, France, 44700 | |
| GSK Investigational Site | |
| Angoulême, France, 16000 | |
| GSK Investigational Site | |
| Paris, France, 75012 | |
| GSK Investigational Site | |
| Arcachon, France, 33120 | |
| Germany | |
| GSK Investigational Site | |
| Berlin, Germany, 13187 | |
| GSK Investigational Site | |
| Berlin, Germany, 10629 | |
| Germany, Baden-Wuerttemberg | |
| GSK Investigational Site | |
| Ulm, Baden-Wuerttemberg, Germany, 89073 | |
| GSK Investigational Site | |
| Ellwangen, Baden-Wuerttemberg, Germany, 73479 | |
| Germany, Hessen | |
| GSK Investigational Site | |
| Huettenberg, Hessen, Germany, 35625 | |
| Germany, Niedersachsen | |
| GSK Investigational Site | |
| Westerstede, Niedersachsen, Germany, 26655 | |
| GSK Investigational Site | |
| Achim, Niedersachsen, Germany, 28832 | |
| Germany, Nordrhein-Westfalen | |
| GSK Investigational Site | |
| Bochum, Nordrhein-Westfalen, Germany, 44869 | |
| GSK Investigational Site | |
| Bochum, Nordrhein-Westfalen, Germany, 44892 | |
| GSK Investigational Site | |
| Hattingen, Nordrhein-Westfalen, Germany, 45525 | |
| GSK Investigational Site | |
| Bielefeld, Nordrhein-Westfalen, Germany, 33647 | |
| Germany, Sachsen | |
| GSK Investigational Site | |
| Dresden, Sachsen, Germany, 01097 | |
| GSK Investigational Site | |
| Chemnitz, Sachsen, Germany, 09111 | |
| GSK Investigational Site | |
| Leipzig, Sachsen, Germany, 04107 | |
| Germany, Sachsen-Anhalt | |
| GSK Investigational Site | |
| Koethen, Sachsen-Anhalt, Germany, 06366 | |
| GSK Investigational Site | |
| Haldensleben, Sachsen-Anhalt, Germany, 39340 | |
| India | |
| GSK Investigational Site | |
| Mumbai,, India, 400 008 | |
| GSK Investigational Site | |
| Bangalore, India, 560034 | |
| GSK Investigational Site | |
| Jaipur, India | |
| GSK Investigational Site | |
| Bangalore, India, 560029 | |
| Latvia | |
| GSK Investigational Site | |
| Riga, Latvia, LV1005 | |
| GSK Investigational Site | |
| Strenci, Latvia, LV4730 | |
| GSK Investigational Site | |
| Jelgava, Latvia, LV3008 | |
| Netherlands | |
| GSK Investigational Site | |
| AMERSFOORT, Netherlands, 3818 ES | |
| GSK Investigational Site | |
| HILVERSUM, Netherlands, 1211 PA | |
| GSK Investigational Site | |
| HOOGVLIET, Netherlands, 3192 JN | |
| GSK Investigational Site | |
| WILDERVANK, Netherlands, 9648 BE | |
| GSK Investigational Site | |
| GRUBBENVORST, Netherlands, 5971 BB | |
| Norway | |
| GSK Investigational Site | |
| Hamar, Norway, N-2317 | |
| GSK Investigational Site | |
| Bergen, Norway, N-5068 | |
| Poland | |
| GSK Investigational Site | |
| Bydgoszcz, Poland, 85-096 | |
| GSK Investigational Site | |
| Choroszcz, Poland, 16-070 | |
| GSK Investigational Site | |
| Torun, Poland, 87-100 | |
| Russian Federation | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 115522 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 119992 | |
| South Africa | |
| GSK Investigational Site | |
| Somerset West, South Africa, 7140 | |
| GSK Investigational Site | |
| Bloemfontein, South Africa | |
| GSK Investigational Site | |
| Cape Town, South Africa, 7460 | |
| GSK Investigational Site | |
| Randburg, Johannesburg, South Africa, 2194 | |
| GSK Investigational Site | |
| Observatory ,Cape Town, South Africa, 7925 | |
| GSK Investigational Site | |
| Vereeniging, South Africa, 1929 | |
| GSK Investigational Site | |
| Danville, South Africa, 0183 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | AK130940 |
| Study First Received: | October 5, 2004 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00093288 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
|
Depression MDD bupropion |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Depression Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Pharmacologic Actions |
Behavioral Symptoms Pathologic Processes Mental Disorders Therapeutic Uses Bupropion Mood Disorders Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |
