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

A Multi-center, Randomized, Double Blind, Parallel, PhaseⅣ Trial to Evaluate the Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
• Intervention / Treatment: Drug: Zyprexa; Drug: A-prexa

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A-prexa; A-prexa 5, 10mg	Drug: Zyprexa; Zyprexa 5-20 mg for 6 weeks
Active Comparator: Zyprexa; Zyprexa 5, 10mg	Drug: A-prexa; A-prexa 5-20 mg for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline at 6 week in total PANSS score	6 week

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: HK inno.N Corporation

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: May 11, 2014
• First Submitted That Met QC Criteria: May 11, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 11, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: CJ_OLZ_401