Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorder
Conditions
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.
Interventions
DRUGA-prexa
A-prexa 5-20 mg for 6 weeks
DRUGZyprexa
Zyprexa 5-20 mg for 6 weeks
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline at 6 week in total PANSS score | 6 week |
Secondary
| 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 |
Outcome results
None listed