Schizophrenia
Conditions
Brief summary
The objective of this clinical trial is to evaluate the safety and efficacy of olanzapine titration schedule in patients with schizophrenia
Interventions
DRUGBR5402A
Subjects take the investigational products once a day
DRUGBR5402A-1
Subjects take the investigational products once a day
DRUGBR5402B
Subjects take the investigational products once a day
DRUGBR5402B-1
Subjects take the investigational products once a day
DRUGBR5402C
Subjects take the investigational products once a day
DRUGBR5402C-1
Subjects take the investigational products once a day
DRUGBR5402D
Subjects take the investigational products once a day
DRUGBR5402D-1
Subjects take the investigational products once a day
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Of patients with schizophrenia in accordance with DSM(Diagnostic and Statistical Manual of Mental Disorders)-5 diagnostic criteria, who are judged that administration of low dose is more appropriate than initial recommended dose or standard titration dose of olanzapine to consider medical conditions by investigator * Patients with the duration of schizophrenia for more than 1 year at screening visit(Visit 1)
Exclusion criteria
* Patients diagnosed schizophrenia spectrum and other psychotic disorder(e.g. schizoaffective disorder, etc.), bipolar disorder, depressive disorder, etc., in accordance with DSM(Diagnostic and Statistical Manual of Mental Disorders)-5 diagnostic criteria at screening visit(Visit 1) * Patients with a history of hospitalization for worsening schizophrenia within 12 weeks at screening visit(Visit 1)
Design outcomes
Primary
| Measure | 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) |
Countries
South Korea
Contacts
Primary ContactShin-young Oh
Outcome results
None listed