This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.

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 II Disorder and currently depressed for minimum of the last 8 weeks.

Exclusion criteria:

• Patients must not be suicidal.
• Patients must not have a history of non-response 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 (014), Los Angeles,  California,  90048,  United States; No longer recruiting
      Study Site (7353), Beverly Hills,  California,  90210,  United States; Recruiting
      Study Site (11572), San Diego,  California,  92108,  United States; Recruiting
      Study Site (26396), Santa Ana,  California,  92705,  United States; Recruiting
Georgia
      Study Site (17147), Marietta,  Georgia,  30060,  United States; Recruiting
Indiana
      Study Site (8316), Terre Haute,  Indiana,  47802,  United States; Recruiting
Kentucky
      Study Site (011), Florence,  Kentucky,  41042,  United States; Terminated
Louisiana
      Study Site (8457), Shreveport,  Louisiana,  71101,  United States; Recruiting
Missouri
      Study Site (16040), St. Charles,  Missouri,  63301,  United States; Recruiting
New Jersey
      Study Site (8853), Clementon,  New Jersey,  08021,  United States; Recruiting
      Study Site (23059), Princeton,  New Jersey,  08540,  United States; Recruiting
New York
      Study Site (19332), New York,  New York,  10021,  United States; Recruiting
      Study Site (19678), Bronx,  New York,  10467,  United States; Recruiting
North Carolina
      Study Site (8815), Raleigh,  North Carolina,  27609,  United States; Recruiting
      Study Site (1899), Charlotte,  North Carolina,  28226,  United States; Recruiting
Ohio
      Study Site (004), Cleveland,  Ohio,  44016,  United States; Terminated
      Study Site (8907), Beachwood,  Ohio,  44122,  United States; Recruiting
Oklahoma
      Study Site (24610), Oklahoma City,  Oklahoma,  73118,  United States; Recruiting
Oregon
      Study Site (25660), Portland,  Oregon,  97210,  United States; Recruiting
      Study Site (9202), Eugene,  Oregon,  97401,  United States; Recruiting
South Carolina
      Study Site (28500), Columbia,  South Carolina,  29201,  United States; Recruiting
Texas
      Study Site (32677), Houston,  Texas,  77058,  United States; Recruiting
      Study Site (10761), Houston,  Texas,  77090,  United States; Recruiting
      Galveston,  Texas,  77555,  United States; Recruiting

Study ID Numbers:  100223
Record last reviewed:  November 2004
Last Updated:  November 12, 2004
Record first received:  February 5, 2004
ClinicalTrials.gov Identifier:  NCT00076882
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08