Overview

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