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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00384033 |
This research study is for outpatient men and women age 18 and older with major depressive disorder (MDD). This study involves the experimental drug desvenlafaxine succinate sustained release (DVS SR).
The purpose of this study is to learn if DVS SR is safe and effective for people with major depressive disorder.
DVS SR affects the activity of 2 neurotransmitters (active chemicals released by the neurons), serotonin and norepinephrine, in your brain. The reference medication used in this study, a currently marketed drug called duloxetine, is an antidepressant medication in the same class as DVS SR, and also affects the activity of serotonin and norephinephrine in the brain.
Participants in this study will be randomly assigned either to receive one of two doses of DVS SR, duloxetine, or placebo.
Participation in the study is voluntary and can last for up to approximately 12 weeks.
Condition | Intervention | Phase |
---|---|---|
Depressive Disorder, Major |
Drug: Desvenlafaxine Sustained-Release Tablets |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Duloxetine-Referenced, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50mg, 100mg) of Desvenlafaxine Sustained-Release Tables in Adult Outpatients With Major Depressive Disorder |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteia:
United States, California | |
Newport Beach, California, United States, 92660 | |
Northridge, California, United States, 91324 | |
Pasadena, California, United States, 91105 | |
Burbank, California, United States, 91506 | |
Beverly Hills, California, United States, 90210 | |
Los Alamitos, California, United States, 90720 | |
Orange, California, United States, 92868 | |
Upland, California, United States, 91786 | |
United States, Florida | |
St. Petersburg, Florida, United States, 33702 | |
Miami, Florida, United States, 33143 | |
United States, Illinois | |
Edwardsville, Illinois, United States, 62025 | |
United States, Michigan | |
Farmington Hills, Michigan, United States, 48336 | |
Flint, Michigan, United States, 48507 | |
Okemos, Michigan, United States, 48864 | |
United States, New Jersey | |
Clementon, New Jersey, United States, 08021 | |
United States, Ohio | |
Dayton, Ohio, United States, 45408 | |
United States, Oregon | |
Portland, Oregon, United States, 97210 | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19149 | |
United States, Utah | |
Salt Lake City, Utah, United States, 84107 | |
United States, Washington | |
Seattle, Washington, United States, 98104 | |
United States, Wisconsin | |
Brown Deer, Wisconsin, United States, 53223 |
Study Director: | Medical Monitor | Wyeth |
Study ID Numbers: | 3151A1-335 |
Study First Received: | October 2, 2006 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00384033 |
Health Authority: | United States: Food and Drug Administration |
MDD Major Depressive Disorder Depression |
Depression O-desmethylvenlafaxine Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Duloxetine Behavioral Symptoms |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Agents Antidepressive Agents Pharmacologic Actions |