The purpose of this study is to evaluate the efficacy and safety of quetiapine in the treatment of a major depressive episode in patients with bipolar disorder.

Condition	Treatment or Intervention	Phase
Bipolar Disorder Depression, Bipolar	Drug: SEROQUEL (quetiapine fumarate) Tablets	Phase III

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

Criteria

Inclusion Criteria:

• Written Informed Consent;
• Bipolar disorder with most recent episode depressed;
• Outpatient status

Exclusion Criteria:

• Patients with a current Axis I disorder other than bipolar disorder within 6 months of screening;
• Patients whose current episode of depression exceeds 12 months or is less than 4 weeks

Alabama
      Birmingham,  Alabama,  United States
California
      Beverly Hills,  California,  United States
      La Mesa,  California,  United States
      San Diego,  California,  United States
Florida
      Jacksonville,  Florida,  United States
      Orlando,  Florida,  United States
      West Palm Beach,  Florida,  United States
      Winter Park,  Florida,  United States
Georgia
      Atlanta,  Georgia,  United States
      Smyrna,  Georgia,  United States
Illinois
      Oakbrook,  Illinois,  United States
Louisiana
      Shreveport,  Louisiana,  United States
New Jersey
      Clementon,  New Jersey,  United States
      Moorestown,  New Jersey,  United States
New York
      New York,  New York,  United States
      Staten Island,  New York,  United States
North Carolina
      Raleigh,  North Carolina,  United States
Ohio
      Cincinnati,  Ohio,  United States
      Cleveland,  Ohio,  United States
      Dayton,  Ohio,  United States
South Carolina
      Columbia,  South Carolina,  United States
Tennessee
      Memphis,  Tennessee,  United States
Texas
      Austin,  Texas,  United States
Utah
      Salt Lake City,  Utah,  United States
Virginia
      Falls Church,  Virginia,  United States
Washington
      Bellevue,  Washington,  United States
      Kirkland,  Washington,  United States

Study ID Numbers:  5077US/0049
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  May 6, 2003
ClinicalTrials.gov Identifier:  NCT00060489
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08