A study to obtain safety and tolerability data

Condition	Treatment or Intervention	Phase
Major Depressive Disorder	Drug: Investigational Depression Drug	Phase IV

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

Criteria

Inclusion: (Patients must meet the following criteria in order to be eligible for this study.)

• Patient must have primary diagnosis of Major Depressive Disorder (MDD).
• Discontinued a selective serotonin reuptake inhibitor (SSRI)or serotonin-norepinephrine reuptake inhibitor (SNRI) regimen due to intolerability.
• Minimum time frame between last dose of previous antidepressant and initiation of study drug is one week.
• Maximum time frame between last dose of prior antidepressant and initiation of study drug is 2 months.

Exclusion: (Patients cannot meet the following criteria in order to be eligible for this study.)

• Patient has previously been treated with the study drug.
• Is experiencing an adverse event attributed to previous SSRI/SNRI use that has not been resolved at least one week prior to Baseline Visit.
• Has a history of seizure disorder.
• Has met criteris for substance abuse or dependence within 6 months prior to Baseline Visit.
• Currently using an antidepressant.
• Currently pregnant.

Alabama
      Fairfield,  Alabama,  35064,  United States
      Birmingham,  Alabama,  35209,  United States
      Mobile,  Alabama,  36695,  United States
      Birmingham,  Alabama,  83704,  United States
Arizona
      Phoenix,  Arizona,  85015,  United States
Arkansas
      Little Rock,  Arkansas,  72111,  United States
      Little Rock,  Arkansas,  72205,  United States
California
      Cerritos,  California,  90703,  United States
      Bellflower,  California,  90706,  United States
      Encino,  California,  91316,  United States
      Vista,  California,  92083,  United States
      Riverside,  California,  92506,  United States
      Temecula,  California,  92591,  United States
      Anaheim,  California,  92801,  United States
      Anaheim Hills,  California,  92807,  United States
      Clovis,  California,  93611,  United States
      San Francisco,  California,  94109,  United States
      Petaluma,  California,  94952,  United States
      Sacramento,  California,  95823,  United States
      Sacramento,  California,  95825,  United States
Colorado
      Colorado Springs,  Colorado,  80904,  United States
Delaware
      Wilmington,  Delaware,  19803,  United States
      Wilmington,  Delaware,  19810,  United States
Florida
      Melbourne,  Florida,  32955,  United States
      North Miami,  Florida,  33161,  United States
      North Miami,  Florida,  33161,  United States
      Boynton Beach,  Florida,  33426,  United States
      Delray Beach,  Florida,  33484,  United States
      Fort Myers,  Florida,  33901,  United States
      Ocala,  Florida,  34474,  United States
Georgia
      Atlanta,  Georgia,  30312,  United States
Idaho
      Idaho Falls,  Idaho,  83404,  United States
Illinois
      Gurnee,  Illinois,  60031,  United States
Indiana
      Greenwood,  Indiana,  46143,  United States
      Indianapolis,  Indiana,  46227,  United States
Louisiana
      Lafayette,  Louisiana,  47905,  United States
      New Orleans,  Louisiana,  70127,  United States
      Lake Charles,  Louisiana,  70601,  United States
Maryland
      Prince Frederick,  Maryland,  20678,  United States
Massachusetts
      Springfield,  Massachusetts,  01107,  United States
Missouri
      St. Louis,  Missouri,  63128,  United States
      St. Charles,  Missouri,  63301,  United States
      Excelsior Springs,  Missouri,  64024,  United States
      Kansas City,  Missouri,  64132,  United States
Nevada
      Las Vegas,  Nevada,  89030,  United States
      Reno,  Nevada,  89501,  United States
New Jersey
      Blackwood,  New Jersey,  08012,  United States
      Princeton,  New Jersey,  08540,  United States
      Mercerville,  New Jersey,  08619,  United States
North Carolina
      Carrboro,  North Carolina,  27510,  United States
      Cary,  North Carolina,  27511,  United States
Ohio
      Cleveland,  Ohio,  44106,  United States
      Independence,  Ohio,  44131,  United States
      Cincinnati,  Ohio,  45219,  United States
      Cincinnati,  Ohio,  45224,  United States
Oklahoma
      Oklahoma City,  Oklahoma,  73112,  United States
Oregon
      Eugene,  Oregon,  97404,  United States
Pennsylvania
      Downingtown,  Pennsylvania,  19335,  United States
Tennessee
      Cordova,  Tennessee,  38018,  United States
      Bartlett,  Tennessee,  38134,  United States
      Selmer,  Tennessee,  38375,  United States
Texas
      Dallas,  Texas,  72505,  United States
      Corsicana,  Texas,  75110,  United States
      Desoto,  Texas,  75115,  United States
      Fort Worth,  Texas,  76137,  United States
      Conroe,  Texas,  77384,  United States
      Sugar Land,  Texas,  77478,  United States
      Galveston,  Texas,  77555,  United States
Utah
      West Valley City,  Utah,  84120,  United States
Virginia
      Richmond,  Virginia,  23230,  United States
      Lebanon,  Virginia,  24266,  United States
Washington
      Kirkland,  Washington,  98034,  United States

Study ID Numbers:  SB29060.833
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 18, 2002
ClinicalTrials.gov Identifier:  NCT00049972
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08