Overview

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

Status:
Completed
Trial end date:
2004-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to examine the clinical therapeutic dose in Japanese agitated patients with schizophrenia.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Olanzapine
Criteria
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