RecruitingPhase 2NCT06821945

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


Sponsor

Boryung Pharmaceutical Co., Ltd

Enrollment

120 participants

Start Date

May 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 19 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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)

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


Locations(2)

Kyungbook National university hospital

Daegu, South Korea

Hanyang University Guri Hospital

Guri-si, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06821945


Related Trials