The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with Bipolar I mania.

Condition	Treatment or Intervention	Phase
Bipolar Disorder	Drug: Quetiapine fumarate	Phase III

Ages Eligible for Study:  10 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patient is able to provide written assent and the parents or legal guardian of the patient is able to provide written informed consent before beginning and study related procedures
• Patient has a documented clinical diagnosis of Bipolar I mania
• Patient’s parent or legal guardian will be able to accompany the patient at each scheduled study visit

Exclusion Criteria:

• Patients (female) must not be pregnant or lactating
• Patients with a known intolerance or lack of response to previous treatment with quetiapine
• Patients who have previously participated in this study

AstraZeneca Information Center (8 AM – 7 PM EST)      1-800-236-9933 

Arizona
      Research Site, Scottsdale,  Arizona,  United States; Recruiting
California
      Research Site, Riverside,  California,  United States; Recruiting
      Research Site, Sacramento,  California,  United States; Not yet recruiting
      Research Site, San Diego,  California,  United States; Recruiting
Colorado
      Research Site, Denver,  Colorado,  United States; Not yet recruiting
Florida
      Research Site, Alamonte,  Florida,  United States; Recruiting
      Research Site, Jacksonville,  Florida,  United States; Recruiting
      Research Site, Miami,  Florida,  United States; Not yet recruiting
Georgia
      Research Site, Augusta,  Georgia,  United States; Recruiting
      Research Site, Augusta,  Georgia,  United States; Recruiting
Illinois
      Research Site, Chicago,  Illinois,  United States; Not yet recruiting
Kansas
      Research Site, Wichita,  Kansas,  United States; Recruiting
Louisiana
      Research Site, New Orleans,  Louisiana,  United States; Not yet recruiting
Missouri
      Research Site, St. Charles,  Missouri,  United States; Recruiting
Nevada
      Research Site, Las Vegas,  Nevada,  United States; Recruiting
New Jersey
      Research Site, Clementon,  New Jersey,  United States; Recruiting
      Research Site, Piscataway,  New Jersey,  United States; Recruiting
New York
      Research Site, Rochester,  New York,  United States; Recruiting
North Carolina
      Research Site, Chapel Hill,  North Carolina,  United States; Not yet recruiting
Ohio
      Research Site, Cincinnati,  Ohio,  United States; Recruiting
      Research Site, Cleveland,  Ohio,  United States; Not yet recruiting
      Research Site, Lyndhurst,  Ohio,  United States; Recruiting
Oklahoma
      Research Site, Oklahoma City,  Oklahoma,  United States; Recruiting
Pennsylvania
      Research Site, Philadelphia,  Pennsylvania,  United States; Recruiting
Tennessee
      Research Site, Madison,  Tennessee,  United States; Recruiting
Texas
      Research Site, Austin,  Texas,  United States; Recruiting
      Research Site, Houston,  Texas,  United States; Recruiting
      Research Site, San Antonio,  Texas,  United States; Recruiting
Virginia
      Research Site, Richmond,  Virginia,  United States; Recruiting
      Research Site, Virginia Beach,  Virginia,  United States; Recruiting
Washington
      Research Site, Bellevue,  Washington,  United States; Recruiting
      Research Site, Kirkland,  Washington,  United States; Recruiting
Wisconsin
      Research Site, Milwaukee,  Wisconsin,  United States; Recruiting

Study ID Numbers:  D1441C00149
Record last reviewed:  March 2005
Last Updated:  March 21, 2005
Record first received:  August 25, 2004
ClinicalTrials.gov Identifier:  NCT00090311
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08