Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia

A Double-Blind Randomized Comparison of the Efficacy and Safety of Intramuscular Olanzapine and Intramuscular Haloperidol in Acutely Agitated Patients With Schizophrenia

The purpose of this study is to compare intramuscular Olanzapine and intramuscular Haloperidol in changing of agitation in patients with schizophrenia

Inclusion Criteria:

• Male or female patients, between the ages of 18 and 65
• Patients must have diagnosis of schizophrenia that meets disease diagnostic criteria as defined in DSM-IV
• Patients must be considered, by the investigator, to be clinically agitated and appropriate candidates for treatment with IM medication. Investigator must believe that it is safe to administer IM olanzapine and IM comparator to the patients with respect to the safety profile of these drugs (including the anticholinergic properties of Olanzapine IM or the comparator agent)
• Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
• Patient must be hospitalized during the study

Exclusion Criteria:

• Previous participation (treatment with study drug) in a Lilly sponsored intra-muscular olanzapine clinical trial
• Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months
• Have a known diagnosis of dementia of any type, as defined in the DSM-IV or DSM-IV-TR
• Documented history of allergic reaction to study medication(s)
• Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration