Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this clinical trial is to evaluate the safety and efficacy of olanzapine titration schedule in patients with schizophrenia
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gradual titration group | Experimental |
| |
| Conventional titration group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR5402A | Drug | Subjects take the investigational products once a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change of PANSS(Positive and Negative Syndrome Scale) total score | 1, 2, 3, 5, 9 weeks from baseline(Visit 2) | |
| Incidence of treatment-emergent adverse events | From the administration of investigational products prescribed at baseline(Visit 2) to 11 weeks(Visit 8) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shin-young Oh | Contact | +82+2-708-8000 | syoh@boryung.co.kr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungbook National university hospital | Recruiting | Daegu | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BR5402A-1 |
| Drug |
Subjects take the investigational products once a day |
|
|
| BR5402B | Drug | Subjects take the investigational products once a day |
|
| BR5402B-1 | Drug | Subjects take the investigational products once a day |
|
|
| BR5402C | Drug | Subjects take the investigational products once a day |
|
| BR5402C-1 | Drug | Subjects take the investigational products once a day |
|
|
| BR5402D | Drug | Subjects take the investigational products once a day |
|
| BR5402D-1 | Drug | Subjects take the investigational products once a day |
|
|
| Hanyang University Guri Hospital | Not yet recruiting | Guri-si | South Korea |
|
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided