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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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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