RECRUITINGPhase 2INTERVENTIONAL
A Clinical Trial to Evaluate the Safety and Efficacy of Olanzapine Titration Schedule in Patients With Schizophrenia
A Multi-Center, Randomized, Double-Blind, Parallel-Design, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Olanzapine Titration Schedule in Patients With Schizophrenia
About This Trial
The objective of this clinical trial is to evaluate the safety and efficacy of olanzapine titration schedule in patients with schizophrenia
Who May Be Eligible (Plain English)
Who May Qualify:
- 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)
Who Should NOT Join This Trial:
- 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)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Treatments Being Tested
DRUG
BR5402A
Subjects take the investigational products once a day
DRUG
BR5402A-1
Subjects take the investigational products once a day
DRUG
BR5402B
Subjects take the investigational products once a day
DRUG
BR5402B-1
Subjects take the investigational products once a day
DRUG
BR5402C
Subjects take the investigational products once a day
DRUG
BR5402C-1
Subjects take the investigational products once a day
DRUG
BR5402D
Subjects take the investigational products once a day
DRUG
BR5402D-1
Subjects take the investigational products once a day
Locations (2)
Kyungbook National university hospital
Daegu, South Korea
Hanyang University Guri Hospital
Guri-si, South Korea