The purposes of this study are to determine:

• Whether olanzapine plus fluoxetine in combination will help patients with treatment-resistant major depression.
• The safety of olanzapine plus fluoxetine in combination, plus and any side effects that might be associated with the combination.
• The effectiveness of olanzapine plus fluoxetine compared to olanzapine and fluoxetine alone.

Condition	Treatment or Intervention	Phase
Depressive Disorders	Drug: Olanzapine  Drug: Fluoxetine	Phase III

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Depressed at least 2 weeks
• At least in a second episode of depression
• Did not respond to an antidepressant medication during the current episode.
• Male or female subjects, 18 to 65 years of age
• Must meet entry severity criterion

Exclusion Criteria:

• Prior use of the combined treatment of the 2 study drugs used in this study.
• Serious and unstable medical conditions.
• Other psychiatric illnesses not allowed by the protocol, for example, schizophrenia, schizoaffective disorder, or bipolar I disorder)
• Current substance abuse or dependence disorders.

There may be multiple sites in this clinical trial      1-877-CTLILLY (1-877-285-4559) 

California
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Vista,  California,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Burbank,  California,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Sherman Oaks,  California,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., San Marcos,  California,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Poway,  California,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Torrance,  California,  United States; Recruiting
Connecticut
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., New London,  Connecticut,  United States; Recruiting
District of Columbia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Washington,  District of Columbia,  United States; Recruiting
Florida
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., St. Petersburg,  Florida,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Orlando,  Florida,  United States; Recruiting
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Coral Springs,  Florida,  United States; Recruiting
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Fort Lauderdale,  Florida,  United States; Recruiting
Georgia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Atlanta,  Georgia,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Marietta,  Georgia,  United States; Recruiting
Idaho
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Boise,  Idaho,  United States; Recruiting
Illinois
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Oak Brook,  Illinois,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Oakbrook Terrace,  Illinois,  United States; Recruiting
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Chicago,  Illinois,  United States; Recruiting
Indiana
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Terre Haute,  Indiana,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Evansville,  Indiana,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Lafayette,  Indiana,  United States; Recruiting
Kansas
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Prairie Village,  Kansas,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Topeka,  Kansas,  United States; Recruiting
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Wichita,  Kansas,  United States; Recruiting
Louisiana
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., New Orleans,  Louisiana,  United States; Recruiting
Maryland
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Glen Burnie,  Maryland,  United States; Recruiting
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Baltimore,  Maryland,  United States; Recruiting
Massachusetts
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Worcester,  Massachusetts,  United States; Recruiting
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Boston,  Massachusetts,  United States; Recruiting
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Belmont,  Massachusetts,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Pittsfield,  Massachusetts,  United States; Recruiting
Michigan
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Farmington Hills,  Michigan,  United States; Recruiting
Missouri
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., St. Louis,  Missouri,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., St. Charles,  Missouri,  United States; Recruiting
New Hampshire
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Nashua,  New Hampshire,  United States; Recruiting
New Jersey
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Moorestown,  New Jersey,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Red Bank,  New Jersey,  United States; Recruiting
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Piscataway,  New Jersey,  United States; Recruiting
New York
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., New York,  New York,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Olean,  New York,  United States; Recruiting
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Orangeburg,  New York,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Baldwin,  New York,  United States; Recruiting
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Lawrence,  New York,  United States; Recruiting
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Staten Island,  New York,  United States; Recruiting
Ohio
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Toledo,  Ohio,  United States; Recruiting
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Cincinnati,  Ohio,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Dayton,  Ohio,  United States; Recruiting
Oklahoma
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Oklahoma City,  Oklahoma,  United States; Recruiting
Oregon
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Medford,  Oregon,  United States; Recruiting
Pennsylvania
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Philadelphia,  Pennsylvania,  United States; Recruiting
Rhode Island
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Lincoln,  Rhode Island,  United States; Recruiting
Tennessee
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Memphis,  Tennessee,  United States; Recruiting
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Nashville,  Tennessee,  United States; Recruiting
Texas
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., El Paso,  Texas,  United States; Recruiting
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Plano,  Texas,  United States; Recruiting
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Houston,  Texas,  United States; Recruiting
Utah
      For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559), Salt Lake City,  Utah,  United States; Recruiting
Vermont
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Burlington,  Vermont,  United States; Recruiting
Virginia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Richmond,  Virginia,  United States; Recruiting
Washington
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Seattle,  Washington,  United States; Recruiting
Wisconsin
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Middleton,  Wisconsin,  United States; Recruiting
Canada
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, St. John,  Canada; Recruiting
Canada, Alberta
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Edmonton,  Alberta,  Canada; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Calgary,  Alberta,  Canada; Recruiting
Canada, British Columbia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Vancouver,  British Columbia,  Canada; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Kelowna,  British Columbia,  Canada; Recruiting
Canada, Newfoundland and Labrador
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., St. John's,  Newfoundland and Labrador,  Canada; Recruiting
Canada, Nova Scotia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Sydney,  Nova Scotia,  Canada; Recruiting
Canada, Ontario
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Kingston,  Ontario,  Canada; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Sudbury,  Ontario,  Canada; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Mississauga,  Ontario,  Canada; Recruiting
Canada, Quebec
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Hull,  Quebec,  Canada; Recruiting

Study ID Numbers:  6272
Record last reviewed:  September 2004
Record first received:  May 2, 2002
ClinicalTrials.gov Identifier:  NCT00035321
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-27