The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.

Condition	Treatment or Intervention	Phase
Bipolar Disorder	Drug: Seroquel®, quetiapine fumarate (atypical antipsychotic)  Drug: lithium (mood stabilizer)  Drug: divalproex (mood stabilizer)	Phase III

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

Criteria

Inclusion Criteria - Open label Phase:

• A diagnosis of Bipolar I Disorder, Most Recent Episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
• At least 1 manic, depressed or mixed episode in the 2 years prior to the index episode
• One of the following: a. A current manic, depressed or mixed episode by DSM-IV criteria. b. A past manic, depressed or mixed episode within 26 weeks as documented by medical records, that was treated with quetiapine and mood stabilizer (lithium or divalproex). Since this episode, treatment with this combination must not have been interrupted for more than 2 weeks continuously.

Inclusion Criteria - Randomized Treatment Phase:

• Has been prescribed a dose of quetiapine within the range 400 to 800 mg/day and mood stabilizer (lithium or divalproex) for at least 12 weeks.
• YMRS ≤12 and MADRS ≤ 12 assessed at a minimum of 4 consecutive visits spanning at least 12 weeks, with the allowance of a single excursion. An excursion is defined as a visit in which the YMRS or MADRS (or both) score equals 13 or 14. The excursion may not occur at the last of the consecutive visits.

Exclusion Criteria - Open-label Phase:

• Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year
• Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator
• Pregnancy or lactation. Female patients of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test at enrollment
• Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria

Exclusion Criteria - Randomized Treatment Phase:

• Hospitalization due to a mood event (manic, depressed or mixed) during the Open-label treatment Phase
• Electroconvulsive therapy (ECT) during the Open-label treatment Phase
• Attempt to commit suicide or homicide during the Open-label treatment Phase
• Substance or alcohol dependence (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria

Alabama
      Research Site, Birmingham,  Alabama,  United States
Arizona
      Research Site, Scottsdale,  Arizona,  United States
Arkansas
      Research Site, Little Rock,  Arkansas,  United States
California
      Research Site, Anaheim,  California,  United States
      Research Site, Cerritos,  California,  United States
      Research Site, Chula Vista,  California,  United States
      Research Site, Garden Grove,  California,  United States
      Research Site, La Mesa,  California,  United States
      Research Site, Culver City,  California,  United States
      Research Site, Oceanside,  California,  United States
      Research Site, Orange,  California,  United States
      Research Site, Pico Rivera,  California,  United States
      Research Site, Rosemead,  California,  United States
      Research Site, Riverside,  California,  United States
      Research Site, San Diego,  California,  United States
      Research Site, San Francisco,  California,  United States
      Research Site, Santa Ana,  California,  United States
Connecticut
      Research Site, Farmington,  Connecticut,  United States
      Research Site, New Britain,  Connecticut,  United States
Florida
      Research Site, Jacksonville,  Florida,  United States
      Research Site, Miami,  Florida,  United States
      Research Site, Orlando,  Florida,  United States
      Research Site, West Palm Beach,  Florida,  United States
      Research Site, Winter Park,  Florida,  United States
Georgia
      Research Site, Atlanta,  Georgia,  United States
      Research Site, Marietta,  Georgia,  United States
      Research Site, Smyrna,  Georgia,  United States
      Research Site, Decatur,  Georgia,  United States
Hawaii
      Research Site, Honolulu,  Hawaii,  United States
Illinois
      Research Site, Chicago,  Illinois,  United States
      Research Site, Hoffman Estates,  Illinois,  United States
      Research Site, Joliet,  Illinois,  United States
Indiana
      Research Site, Evansville,  Indiana,  United States
      Research Site, Greenwood,  Indiana,  United States
      Research Site, Indianapolis,  Indiana,  United States
Kansas
      Research Site, Wichita,  Kansas,  United States
Kentucky
      Research Site, Florence,  Kentucky,  United States
Louisiana
      Research Site, New Orleans,  Louisiana,  United States
      Research Site, Shreveport,  Louisiana,  United States
      Research Site, Lake Charles,  Louisiana,  United States
Maryland
      Research Site, Baltimore,  Maryland,  United States
      Research Site, Rockville,  Maryland,  United States
Massachusetts
      Research Site, Pittsfield,  Massachusetts,  United States
Michigan
      Research Site, New Baltimore,  Michigan,  United States
Missouri
      Research Site, St. Louis,  Missouri,  United States
New Jersey
      Research Site, Clementon,  New Jersey,  United States
      Research Site, Moorestown,  New Jersey,  United States
      Research Site, West Caldwell,  New Jersey,  United States
New Mexico
      Research Site, Albuquerque,  New Mexico,  United States
New York
      Research Site, Bronx,  New York,  United States
      Research Site, Brooklyn,  New York,  United States
      Research Site, New York,  New York,  United States
North Carolina
      Research Site, Butner,  North Carolina,  United States
      Research Site, Raleigh,  North Carolina,  United States
Ohio
      Research Site, Beachwood,  Ohio,  United States
      Research Site, Cincinnati,  Ohio,  United States
      Research Site, Dayton,  Ohio,  United States
      Research Site, Medina,  Ohio,  United States
Oklahoma
      Research Site, Oklahoma City,  Oklahoma,  United States
      Research Site, Tulsa,  Oklahoma,  United States
Oregon
      Research Site, Eugene,  Oregon,  United States
      Research Site, Portland,  Oregon,  United States
Pennsylvania
      Research Site, Emmaus,  Pennsylvania,  United States
      Research Site, Moon Township,  Pennsylvania,  United States
      Research Site, Philadelphia,  Pennsylvania,  United States
South Carolina
      Research Site, Charleston,  South Carolina,  United States
Tennessee
      Research Site, Memphis,  Tennessee,  United States
Texas
      Research Site, Austin,  Texas,  United States
      Research Site, Dallas,  Texas,  United States
      Research Site, Desoto,  Texas,  United States
      Research Site, Houston,  Texas,  United States
      Research Site, Irving,  Texas,  United States
      Research Site, San Antonio,  Texas,  United States
      Research Site, Wichita Falls,  Texas,  United States
Virginia
      Research Site, Charlottesville,  Virginia,  United States
      Research Site, Falls Church,  Virginia,  United States
      Research Site, Virginia Beach,  Virginia,  United States
      Research Site, Richmond,  Virginia,  United States
Washington
      Research Site, Bellevue,  Washington,  United States
      Research Site, Kirkland,  Washington,  United States
West Virginia
      Research Site, Morgantown,  West Virginia,  United States
Canada
      Research Site, Quebec,  Canada
Canada, Alberta
      Research Site, Edmonton,  Alberta,  Canada
Canada, British Columbia
      Research Site, Vancouver,  British Columbia,  Canada
      Research Site, Victoria,  British Columbia,  Canada
Canada, Manitoba
      Research Site, Winnipeg,  Manitoba,  Canada
Canada, Nova Scotia
      Research Site, Halifax,  Nova Scotia,  Canada
Canada, Ontario
      Research Site, Hamilton,  Ontario,  Canada
      Research Site, Kingston,  Ontario,  Canada
      Research Site, Markham,  Ontario,  Canada
      Research Site, Mississauga,  Ontario,  Canada
      Research Site, Oshawa,  Ontario,  Canada
      Research Site, Toronto,  Ontario,  Canada
Canada, Quebec
      Research Site, Montreal,  Quebec,  Canada
      Research Site, Verdun,  Quebec,  Canada

Study ID Numbers:  D1447C00127
Record last reviewed:  March 2005
Last Updated:  March 21, 2005
Record first received:  April 9, 2004
ClinicalTrials.gov Identifier:  NCT00081380
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08