The purpose of this study is to demonstrate superior efficacy of quetiapine fumarate (SEROQUEL) compared with placebo when used as an adjunct to mood stabilizers in the maintenance treatment of bipolar I disorders.

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

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

Criteria

Inclusion Criteria:

• Patient is able to provide written informed consent before beginning any study related procedures
• Patient has a documented clinical diagnosis of bipolar I disorder
• Patient is able to understand and comply with the requirements of the study as judged by a study investigator

Exclusion Criteria:

• Patients with a history of non-compliance as judged by the study investigator
• Patients with a known lack of response to previous treatment with quetiapine or to the assigned mood stabilizer
• Patients who have used an experimental drug within 30 days of enrollment
• Patients who have previously participated in this study or study D144700127

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Alabama
      Research Site, Birmingham,  Alabama,  United States
California
      Research Site, San Francisco,  California,  United States
      Research Site, Beverly Hills,  California,  United States
      Research Site, Santa Ana,  California,  United States
      Research Site, Anaheim,  California,  United States
      Research Site, Redlands,  California,  United States
      Research Site, Westminster,  California,  United States
      Research Site, Chula Vista,  California,  United States
Colorado
      Research Site, Denver,  Colorado,  United States
Florida
      Research Site, Miami,  Florida,  United States
      Research Site, Sarasota,  Florida,  United States
      Research Site, Jacksonville,  Florida,  United States
      Research Site, Gainesville,  Florida,  United States
      Research Site, Winter Park,  Florida,  United States
Illinois
      Research Site, Granite City,  Illinois,  United States
      Research Site, Schaumburg,  Illinois,  United States
Louisiana
      Research Site, Metairie,  Louisiana,  United States
Maryland
      Research Site, Glen Burnie,  Maryland,  United States
Missouri
      Research Site, St. Charles,  Missouri,  United States
      Research Site, St. Louis,  Missouri,  United States
New York
      Research Site, Rochester,  New York,  United States
      Research Site, Olean,  New York,  United States
      Research Site, Brooklyn,  New York,  United States
Oklahoma
      Research Site, Oklahoma City,  Oklahoma,  United States
Oregon
      Research Site, Portland,  Oregon,  United States
Pennsylvania
      Research Site, Philadelphia,  Pennsylvania,  United States
      Research Site, Havertown,  Pennsylvania,  United States
      Research Site, Media,  Pennsylvania,  United States
South Carolina
      Research Site, Morgonton,  South Carolina,  United States
Tennessee
      Research Site, Memphis,  Tennessee,  United States
Texas
      Research Site, Houston,  Texas,  United States
      Research Site, Conroe,  Texas,  United States
Washington
      Research Site, Seattle,  Washington,  United States
Wisconsin
      Research Site, Milwaukee,  Wisconsin,  United States

Study ID Numbers:  D1447C00126
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  April 7, 2005
ClinicalTrials.gov Identifier:  NCT00107731
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08