The main objective of this study is to compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with Major Depressive Disorder.

Condition	Treatment or Intervention	Phase
Depression Depressive Disorder Major Depressive Disorder	Drug: DVS-233 SR	Phase III

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

Criteria

Inclusion Criteria:

• Outpatients.
• Men and women age 18 years of age and older.
• Women of childbearing potential participating in the study must have a negative serum pregnancy test result at screening and use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used double-barrier contraception (e.g. condom plus diaphragm).
• Subjects must have a primary diagnosis of major depressive disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), single or recurrent episode, without psychotic features. If other allowable psychiatric diagnoses are present, MDD must be the predominant psychiatric disorder present.
• Depressive symptoms for at least 30 days before the screening visit.
• Signed and dated informed consent before any screening procedures.

Exclusion Criteria:

• Treatment with DVS-233 SR at any time in the past.
• Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day 1.
• Known hypersensitivity to venlafaxine (IR or ER).
• Significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
• Additional criteria to be evaluated during screening.

California
      California Clinical Trials, Glendale,  California,  91206,  United States
      Southwestern Research, Inc., Beverly Hills,  California,  90210,  United States
Colorado
      Feiger Health Research Center, Wheat Ridge,  Colorado,  80033,  United States
Florida
      CORE Research of Florida, Inc., Winter Park,  Florida,  32789,  United States
Georgia
      Carman Research, Smyrna,  Georgia,  30080,  United States
New Jersey
      CNS Research Institute (CRI), Clementon,  New Jersey,  08021,  United States
Oregon
      Summit Research Network (Oregon) Inc., Portland,  Oregon,  97209,  United States
Utah
      Radiant Research, Salt Lake City,  Utah,  84107,  United States
Washington
      Northwest Clinical Research Center, Bellevue,  Washington,  98004,  United States
      Summit Research Network (Seattle) LLC, Seattle,  Washington,  98104,  United States

Study ID Numbers:  3151A1-320-US
Record last reviewed:  March 2005
Last Updated:  March 4, 2005
Record first received:  September 24, 2004
ClinicalTrials.gov Identifier:  NCT00092911
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08