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

• Patients must provide written and informed consent.
• Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks.

Exclusion

• 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
      Beverly Hills,  California,  90210,  United States; Recruiting
      San Diego,  California,  92108,  United States; Recruiting
      Santa Ana,  California,  92705,  United States; Recruiting
Georgia
      Marietta,  Georgia,  30060,  United States; Recruiting
Indiana
      Terre Haute,  Indiana,  47802,  United States; Recruiting
Kentucky
      Study Site (011), Florence,  Kentucky,  41042,  United States; Terminated
Louisiana
      Shreveport,  Louisiana,  71101,  United States; Not yet recruiting
New Jersey
      Clementon,  New Jersey,  08021,  United States; Recruiting
      Princeton,  New Jersey,  08540,  United States; Recruiting
New York
      New York,  New York,  10021,  United States; Recruiting
      Bronx,  New York,  10467,  United States; Recruiting
North Carolina
      Raleigh,  North Carolina,  27609,  United States; Recruiting
Ohio
      Study Site (004), Cleveland,  Ohio,  44016,  United States; Terminated
      Beachwood,  Ohio,  44122,  United States; Not yet recruiting
Oregon
      Portland,  Oregon,  97210,  United States; Recruiting
      Eugene,  Oregon,  97401,  United States; Recruiting
South Carolina
      Columbia,  South Carolina,  29201,  United States; Recruiting
Texas
      Houston,  Texas,  77058,  United States; Recruiting
      Study Site (008), Houston,  Texas,  77090,  United States; Recruiting
      Galveston,  Texas,  77555,  United States; Recruiting

Study ID Numbers:  100223
Record last reviewed:  July 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 2004-11-10