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

Lilly

Status and phase

Completed

Phase 2

Phase 1

Conditions

Schizophrenia

Treatments

Drug: Olanzapine Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

5293

F1D-JE-RA01

Details and patient eligibility

About

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

Enrollment

31 patients

Sex

All

Ages

20 to 64 years old

Volunteers

No Healthy Volunteers

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