Lead Sponsor

Eli Lilly and Company

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Male or female in- or out-patients at least 18 years of age
•Patient must have a diagnosis of bipolar I disorder and currently display acute manic or mixed episodes (with or without psychotic features) according to the DSM-IV based on clinical assessment
•Patients must have a level of understanding sufficient to agree to all tests and examinations required by the protocol
•Patients must have a Y-MRS total score of greater than or equal to 20 at both visits 1 \& 2
•Patients must be considered reliable

•Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
•Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months
•Current or past diagnosis of schizophrenia or other psychotic disorder (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV
•Documented history of intolerance to olanzapine or Lithium Carbonate
•Treatment with clozapine within 4 weeks prior to visit 2. Treatment with other antipsychotic drugs or mood stabilizers within 2 days prior to visit 2