The purpose of this study is to evaluate the safety of the investigational medication in patients with bipolar disorder.

Condition	Treatment or Intervention	Phase
Bipolar Disorder	Drug: Investigational Bipolar Disorder Drug	Phase III

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

Criteria

Inclusion criteria:

• Patients must provide written and informed consent
• Diagnosis of Bipolar I Disorder and currently depressed for minimum of the previous 8 weeks
• Patients must have been hospitalized for mood disorder or incarceration with or without formal charges as the result of mania related behavior
• Patients must not be suicidal
• Patients must not have a history or non-reponse to antidepressant treatment
• Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry
• Patients must not have had epilepsy or hypothyroidism

California
      Study Site (4822), Los Angeles,  California,  90048,  United States; No longer recruiting
      Study Site (4820), Beverly Hills,  California,  90210,  United States; Recruiting
      Study Site (43067), San Diego,  California,  92018,  United States; Recruiting
      Study Site (26396), Santa Ana,  California,  92705,  United States; Recruiting
Georgia
      Study Site (67188), Marietta,  Georgia,  30060,  United States; Recruiting
Indiana
      Study Site (14379), Terre Haute,  Indiana,  47802,  United States; Recruiting
Kentucky
      Study Site (3889), Florence,  Kentucky,  41042,  United States; No longer recruiting
New Jersey
      Study Site (23059), Princeton,  New Jersey,  08540-2859,  United States; Recruiting
New York
      Study Site (2539), New York,  New York,  10021,  United States; Recruiting
      Study Site (3941), Bronx,  New York,  10467,  United States; Recruiting
North Carolina
      Study Site (2783), Raleigh,  North Carolina,  27609,  United States; Recruiting
Ohio
      Study Site (44051), Cleveland,  Ohio,  44106,  United States; No longer recruiting
      Study Site (8907), Beachwood,  Ohio,  44122,  United States; Not yet recruiting
Oregon
      Study Site (18215), Portland,  Oregon,  92710,  United States; Recruiting
      Study Site (84054), Eugene,  Oregon,  97401,  United States; Recruiting
South Carolina
      Study Site (48191), Columbia,  South Carolina,  29201,  United States; Recruiting
Texas
      Study Site (51542), Houston,  Texas,  77090,  United States; Recruiting
Wisconsin
      Study Site (6301), Brown Deer,  Wisconsin,  53223,  United States; No longer recruiting

Study ID Numbers:  SCA30924
Record last reviewed:  September 2004
Record first received:  March 10, 2003
ClinicalTrials.gov Identifier:  NCT00056277
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10