Study Evaluating Desvenlafaxine Sustained-Release (DVS-SR) in Adult Outpatients With Major Depressive Disorder
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00277823 |
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Recruitment Status :
Completed
First Posted : January 16, 2006
Last Update Posted : December 28, 2007
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Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
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Brief Summary:
The purpose of this study is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS-SR versus subjects receiving placebo.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Major Depressive Disorder | Drug: DVS-SR 50 mg Drug: DVS-SR 100 mg Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 480 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder |
| Study Start Date : | February 2006 |
| Actual Study Completion Date : | January 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
Primary Outcome Measures :
- The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo.
Secondary Outcome Measures :
- Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical diagnosis of major depressive disorder
- Must be able to swallow tablets
- Must be at least 18 years of age.
Exclusion Criteria:
- Clinical diagnosis of other psychiatric disorders
- Significant risk of suicide
- Unstable medical conditions.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277823
Locations
| United States, California | |
| Beverly Hills, California, United States, 90210 | |
| Northridge, California, United States, 91324 | |
| United States, Connecticut | |
| Farmington, Connecticut, United States, 06030 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Miami, Florida, United States, 33173 | |
| St. Petersburg, Florida, United States, 33702 | |
| United States, Georgia | |
| Marietta, Georgia, United States, 30060 | |
| Smyrna, Georgia, United States, 30080 | |
| United States, Illinois | |
| Libertyville, Illinois, United States, 60048 | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States, 70115 | |
| United States, Michigan | |
| Farmington Hills, Michigan, United States, 48336 | |
| United States, New Jersey | |
| Clementon, New Jersey, United States, 08021 | |
| Moorestown, New Jersey, United States, 08057 | |
| United States, New York | |
| New York, New York, United States, 10021 | |
| New York, New York, United States, 10024 | |
| United States, Ohio | |
| Dayton, Ohio, United States, 45408 | |
| Toledo, Ohio, United States, 43623 | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29407 | |
| Columbia, South Carolina, United States, 29201 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Washington | |
| Seattle, Washington, United States | |
| United States, Wisconsin | |
| Brown Deer, Wisconsin, United States, 53223 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00277823 |
| Other Study ID Numbers: |
3151A1-332 |
| First Posted: | January 16, 2006 Key Record Dates |
| Last Update Posted: | December 28, 2007 |
| Last Verified: | December 2007 |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
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Depression Adult Outpatients |
Additional relevant MeSH terms:
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Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |