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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2004-11-30

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Olanzapine Hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Sapporo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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F1D-JE-RA01

Identifier Type: -

Identifier Source: secondary_id

5293