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

HK inno.N

Status and phase: Completed; Phase 4

Conditions: Schizophreniform Disorder; Schizophrenia; Schizoaffective Disorder

Treatments: Drug: A-prexa; Drug: Zyprexa

Study type: Interventional

Funder types: Industry

Identifiers

NCT02137993

CJ_OLZ_401

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups

A-prexa

Experimental group

Description:

A-prexa 5, 10mg

Treatment:

Drug: Zyprexa

Zyprexa

Active Comparator group

Description:

Zyprexa 5, 10mg

Treatment:

Drug: A-prexa