The purpose of this study is to determine whether quetiapine fumarate (Seroquel®) when used as monotherapy, is safe and effective in the treatment of adult patients with Bipolar I or II Disorder as compared to Paxil or placebo (inert substance). The study consists of 2 phases, an 8-week acute treatment period followed by a 26 to 52 week continuation phase.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Seroquel®, (atypical antipsychotic)  Drug: Paxil (Selective Serotonin Re-Uptake Inhibitor)	Phase III

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

Criteria

Inclusion Criteria:

• Must provide written informed consent prior to any study related procedures.
• Must be diagnosed with bipolar I disorder or bipolar II disorder, with most recent episode depressed.

Exclusion Criteria:

• Have a recent history of substance/alcohol abuse
• Pregnancy or breastfeeding
• Have a known history of intolerance or lack of response to quetiapine (Seroquel®) or paroxetine
• Use any other medication for their bipolar disorder or depression other than study drug
• Have participated in another drug study within 30 days of enrollment

Please refer to this study by ClinicalTrials.gov identifier  NCT00119652

AstraZeneca Information Center      1-800-236-9933 

Arizona
      Research Site, Phoenix,  Arizona,  United States; Recruiting
Arkansas
      Research Site, Little Rock,  Arkansas,  United States; Recruiting
California
      Research Site, National City,  California,  United States; Recruiting
      Research Site, San Diego,  California,  United States; Recruiting
Florida
      Research Site, Maitland,  Florida,  United States; Recruiting
Georgia
      Research Site, Atlanta,  Georgia,  United States; Not yet recruiting
      Research Site, Smyrna,  Georgia,  United States; Recruiting
Illinois
      Research Site, Oak Brook,  Illinois,  United States; Recruiting
      Research Site, Northfield,  Illinois,  United States; Recruiting
Louisiana
      Research Site, New Orleans,  Louisiana,  United States; Recruiting
      Research Site, Shreveport,  Louisiana,  United States; Not yet recruiting
Maryland
      Research Site, Glen Burnie,  Maryland,  United States; Recruiting
Missouri
      Research Site, St. Louis,  Missouri,  United States; Recruiting
      Research Site, Bridgeton,  Missouri,  United States; Not yet recruiting
New Jersey
      Research Site, Clementon,  New Jersey,  United States; Recruiting
North Carolina
      Research Site, Raleigh,  North Carolina,  United States; Recruiting
Ohio
      Research Site, Cincinnati,  Ohio,  United States; Recruiting
      Research Site, Dayton,  Ohio,  United States; Recruiting
Oklahoma
      Research Site, Oklahoma City,  Oklahoma,  United States; Recruiting
Pennsylvania
      Research Site, Philadelphia,  Pennsylvania,  United States; Recruiting
Texas
      Research Site, Austin,  Texas,  United States; Recruiting
      Research Site, Dallas,  Texas,  United States; Not yet recruiting
      Research Site, Irving,  Texas,  United States; Recruiting
Virginia
      Research Site, Richmond,  Virginia,  United States; Recruiting
Washington
      Research Site, Bellevue,  Washington,  United States; Recruiting
      Research Site, Kirkland,  Washington,  United States; Recruiting
      Research Site, Spokane,  Washington,  United States; Not yet recruiting

Study ID Numbers:  D1447C00134
Record last reviewed:  July 2005
Last Updated:  July 18, 2005
Record first received:  July 14, 2005
ClinicalTrials.gov Identifier:  NCT00119652
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26