Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective disorder.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CJ HealthCare Corporation; HK inno.N Corporation
• Treatments: Olanzapine

Criteria

Inclusion Criteria:

• 20 years to 65 years

• Schizophrenia patient with an acute exacerbation

• Understand the requirement of the study and voluntarily consent to participate in the study

Exclusion Criteria:

• Patients who have another psychiatric disorders

• Patients who have unstable medical conditions

• Patients who have clinically important abnormalities of liver function test (>2.5 fold of upper normal limit), ECG and vital sign at screening visit

• Uncontrolled diabetic patients (plasma glucose level is more than 126 mg/dl in fasting condition)

• Patients who have a history of an allergic reaction to olanzapine

• Patient who have no clinical response to take two or more different atypical anti-psychotics for more than 4 weeks.

• Patient who take clozapine within 12 weeks before screening visit