A Clinical Trial to Evaluate the Safety and Efficacy of Olanzapine Titration Schedule in Patients With Schizophrenia

Boryung

Status and phase: Enrolling; Phase 2

Conditions: Schizophrenia

Treatments: Drug: BR5402A-1; Drug: BR5402B; Drug: BR5402B-1; Drug: BR5402D; Drug: BR5402A; Drug: BR5402C-1; Drug: BR5402C; Drug: BR5402D-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT06821945

BR-OLZ-CT-201

Details and patient eligibility

About

The objective of this clinical trial is to evaluate the safety and efficacy of olanzapine titration schedule in patients with schizophrenia

Enrollment: 120 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Gradual titration group

Experimental group

Treatment:

Drug: BR5402D-1

Drug: BR5402C

Drug: BR5402C-1

Drug: BR5402A

Drug: BR5402D

Drug: BR5402B

Conventional titration group

Active Comparator group

Treatment:

Drug: BR5402C

Drug: BR5402C-1

Drug: BR5402D

Drug: BR5402B-1

Drug: BR5402A-1