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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-prexa | Experimental | A-prexa 5, 10mg |
|
| Zyprexa | Active Comparator | Zyprexa 5, 10mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-prexa | Drug | A-prexa 5-20 mg for 6 weeks |
| |
| Zyprexa |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline at 6 week in total PANSS score | 6 week |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
Zyprexa 5-20 mg for 6 weeks |
|
| 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 |
| D006571 | Heterocyclic Compounds |