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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485810
• Other study ID #: 5293
• Secondary ID: F1D-JE-RA01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 11, 2007
• Last updated: June 11, 2007
• Start date: June 2004
• Est. completion date: November 2004

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Olanzapine Hydrochloride

Locations

Country	Name	City	State
Japan	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to examine the safety and efficacy of the clinical therapeutic dose of IM olanzapine (7.5 mg/inj and 10 mg/inj) in Japanese agitated patients with schizophrenia
Secondary	To examine the efficacy of IM olanzapine by evaluating change from baseline to 24 hours following the first IM injection in the PANSS Excited Component Total Score and the ACES
Secondary	To examine the characteristics of sedation for each treatment group based on the ACES score
Secondary	To examine a frequency of patients who needed second injection

External Links

•   Lilly Clinical Trial Registry