The goals of this study are: A. To determine whether olanzapine can help patients with bipolar disorder who currently have mild to moderate mania. B. To assess the safety of olanzapine and any side effects that might be associated with it, as well as the quality of life and functioning of patients treated with olanzapine. C. To assess how olanzapine compares to divalproex.

Condition	Treatment or Intervention	Phase
Bipolar Disorder	Drug: Olanzapine  Drug: Divalproex	Phase IV

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

Criteria

Inclusion Criteria:

• You must be 18 to 65 years old.
• You must have a diagnosis of bipolar I disorder and must be experiencing a manic or mixed (symptoms of mania and depression occurring together) episode.
• You must be able to visit the doctor's office as scheduled for 15 weeks.
• All female patients must test negative for pregnancy and, if of childbearing potential, must be using a medically accepted means of contraception.

Exclusion Criteria:

• You have rapid cycling bipolar disorder, or are having hallucinations or delusions, or are feeling suicidal.
• You are pregnant or breastfeeding
• You have a history of: inadequately controlled diabetes; heart disease; narrow angle glaucoma; low white blood cell or platelet count; have a positive test result for human immunodeficiency virus (HIV+); or any other serious, unstable illnesses as judged by the study physician.

"There may be multiple sites in this clinical trial."      1-877-CTLILLY (1-877-285-4559) 

California
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Fresno,  California,  United States; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Los Angeles,  California,  United States; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Orange,  California,  United States; Recruiting
District of Columbia
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Washington,  District of Columbia,  United States; Recruiting
Georgia
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Atlanta,  Georgia,  United States; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Marietta,  Georgia,  United States; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Decatur,  Georgia,  United States; Recruiting
Idaho
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Boise,  Idaho,  United States; Recruiting
Indiana
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Indianapolis,  Indiana,  United States; Recruiting
Kentucky
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Florence,  Kentucky,  United States; Recruiting
Nevada
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Reno,  Nevada,  United States; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Reno,  Nevada,  United States; Recruiting
Pennsylvania
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Media,  Pennsylvania,  United States; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Media,  Pennsylvania,  United States; Recruiting
Texas
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Austin,  Texas,  United States; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Houston,  Texas,  United States; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Dallas,  Texas,  United States; Recruiting
Washington
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Bellevue,  Washington,  United States; Recruiting
France
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Dole,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., La Rochelle,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Le Havre,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Limoges,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Montpellier Cedex 5,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Paris,  France; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Poitiers,  France; Recruiting
Germany
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Bonn,  Germany; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Chemitz,  Germany; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Chemnitz,  Germany; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Osnabruck,  Germany; Recruiting
Germany, Bayern
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Munchen,  Bayern,  Germany; Recruiting
Lithuania
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Klaipeda,  Lithuania; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Siauliai,  Lithuania; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Vilnius,  Lithuania; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Ziegzdriu K,  Lithuania; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Kaunas,  Lithuania; Recruiting
Poland
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Bydgoszcz,  Poland; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Chelmno,  Poland; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Choroszcz,  Poland; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Syntonia,  Poland; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Torun,  Poland; Recruiting
Romania
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Craiova,  Romania; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Iasi,  Romania; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Tg. Mures,  Romania; Recruiting
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Timisoara,  Romania; Recruiting
Romania, Cluj
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician., Cluj Napoca,  Cluj,  Romania; Recruiting
Russian Federation
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Moscow,  Russian Federation; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Saint Petersburg,  Russian Federation; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", St Petersburg,  Russian Federation; Recruiting
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Yareslavi,  Russian Federation; Recruiting
Russian Federation, Udmurtian Republic
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Izhevsk,  Udmurtian Republic,  Russian Federation; Recruiting

Study ID Numbers:  7029
Record last reviewed:  January 2005
Last Updated:  January 21, 2005
Record first received:  October 20, 2004
ClinicalTrials.gov Identifier:  NCT00094549
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08