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

NCT00485810 | Completed Phase 1

• 2 other identifiers: 5293F1D-JE-RA01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• To examine the characteristics of sedation for each treatment group based on the ACES score

• To examine a frequency of patients who needed second injection

Interventions

Olanzapine Hydrochloride DRUG

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Schizophrenia

Interventions

olanzapine-fluoxetine combination

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 13, 2007
• Study Start: June 1, 2004
• Study Completion: November 1, 2004
• Last Updated: June 13, 2007

Record last verified: 2007-06

Locations

JP (1)