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

Phase 4

Completed

• Conditions: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder
• Interventions: Drug: A-prexa; Drug: Zyprexa

• Registration Number: NCT02137993
• Lead Sponsor: HK inno.N Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-05
• Study First Submitted: 2014-05-11
• Study First Submitted QC: 2014-05-11
• Last Update Submitted: 2014-05-11
• Study First Posted: 2014-05-14
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zyprexa	A-prexa	Zyprexa 5, 10mg
A-prexa	Zyprexa	A-prexa 5, 10mg

Primary Outcome Measures

Name	Time	Method
Change from baseline at 6 week in total PANSS score	6 week

Secondary Outcome Measures

Name	Time	Method
Change from baseline at 1, 2, 4 and 6 week in total PANSS score.	6 week
Responder to be decreased of 30% or more in PANSS total score from baseline at 6 week	6 week
Change from baseline at 6 week in total CGI-S score	6 week
Responder rate in CGI-I score of 'very much improved', 'much improved' and 'minimally improved'	6 week