Examining Rapid Acting Intra-Muscular Olanzapine in Japanese Patients With Schizophrenia

A Study Examining Clinical Therapeutic Dose of Rapid Acting Intra-Muscular Olanzapine in Japanese Agitated Patients With Schizophrenia

The purpose of this study is to examine the clinical therapeutic dose in Japanese agitated patients with schizophrenia.

Inclusion Criteria:

• Male or female patients at least 20 years of age and less than 65 years old
• Patients must be inpatients during the study
• Patients must have a diagnosis of schizophrenia as per the DSM-IV, as determined by the investigator
• Patients must be considered by the investigator to be clinically agitated and to be clinically appropriate candidates for the treatment with intramuscular (IM) medication
• Patients must have a minimum total score of greater than or equal to 14 on the 5 items of the PANSS-EC and at least one individual item score of greater than or equal to 4 using the 1-7 scoring system, prior to the first IM injection of study drug

Exclusion Criteria:

• Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months. This includes hepatic (specifically any degree of jaundice), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases
• Known history of seizures; however, a patient whose etiology is identifiable and has been resolved may be enrolled
• Known history of diabetes mellitus, complications of diabetes mellitus, or potential diabetes mellitus as defined by patients with single blood glucose measurement based on site tests; patients with values greater than or equal to 140 mg/dL (non-fasting) or greater than or equal to 110 mg/dL (fasting) must be excluded from the study
• History of allergic reaction or intolerance to olanzapine
• Have received treatment with psychostimulants or reserpine within 1 week prior to study drug administration