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	Intervention	Phase
Major Depressive Disorder Adult Outpatients	Drug: DVS SR 50 mg  Drug: DVS SR 100 mg  Drug: Placebo	Phase III

Further study details as provided by Wyeth:

Primary Outcomes: 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 Outcomes: Additional objectives include testing both general and functional quality-of-life; outcomes and satisfaction with therapy reported by the subject.
Expected Total Enrollment:  480

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00277823

Trial Manager       clinicaltrialinfo@wyeth.com

California
      Northridge,  California,  91324,  United States
      Beverly Hills,  California,  90210,  United States
Connecticut
      Farmington,  Connecticut,  06030,  United States
District of Columbia
      Washington,  District of Columbia,  20037,  United States
Florida
      St. Petersburg,  Florida,  33702,  United States
      Miami,  Florida,  33173,  United States
Georgia
      Smyrna,  Georgia,  30080,  United States
      Marietta,  Georgia,  30060,  United States
Illinois
      Libertyville,  Illinois,  60048,  United States
Louisiana
      New Orleans,  Louisiana,  70115,  United States
Michigan
      Farmington Hills,  Michigan,  48336,  United States
New Jersey
      Clementon,  New Jersey,  08021,  United States
      Moorestown,  New Jersey,  08057,  United States
New York
      New York,  New York,  10024,  United States
      New York,  New York,  10021,  United States
Ohio
      Dayton,  Ohio,  45408,  United States
      Toledo,  Ohio,  43623,  United States
Oklahoma
      Oklahoma City,  Oklahoma,  73103,  United States
Oregon
      Portland,  Oregon,  97210,  United States
Pennsylvania
      Philadelphia,  Pennsylvania,  United States
South Carolina
      Columbia,  South Carolina,  29201,  United States
      Charleston,  South Carolina,  29407,  United States
Utah
      Salt Lake City,  Utah,  84107,  United States
Washington
      Seattle,  Washington,  United States
Wisconsin
      Brown Deer,  Wisconsin,  53223,  United States

Study chairs or principal investigators

Medical Monitor,  Study Director,  Wyeth Research   

Study ID Numbers:  3151A1-332
Last Updated:  January 13, 2006
Record first received:  January 12, 2006
ClinicalTrials.gov Identifier:  NCT00277823
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-17