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Completed

NCT Number: NCT02137993

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Schizophreniform Disorder

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A-prexa

Drug

A-prexa 5-20 mg for 6 weeks

Zyprexa

Drug

Zyprexa 5-20 mg for 6 weeks

Primary outcomes

  1. Change from baseline at 6 week in total PANSS score

    Time frame: 6 week

Secondary outcomes

  1. Change from baseline at 1, 2, 4 and 6 week in total PANSS score.

    Time frame: 6 week

  2. Responder to be decreased of 30% or more in PANSS total score from baseline at 6 week

    Time frame: 6 week

  3. Change from baseline at 6 week in total CGI-S score

    Time frame: 6 week

  4. Responder rate in CGI-I score of 'very much improved', 'much improved' and 'minimally improved'

    Time frame: 6 week

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 14, 2014
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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