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Study Evaluating Desvenlafaxine Sustained-Release (DVS-SR) in Adult Outpatients With Major Depressive Disorder

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
Recruitment Status : Completed
First Posted : January 16, 2006
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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

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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





Primary Outcome Measures :
  1. 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 :
  1. 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
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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
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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):

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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:
Depression
Adult
Outpatients
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms