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

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

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: BR5402A; Drug: BR5402B; Drug: BR5402C; Drug: BR5402C-1; Drug: BR5402D; Drug: BR5402D-1; Drug: BR5402A-1; Drug: BR5402B-1

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shin-young Oh; Phone Number: +82+2-708-8000; Email: syoh@boryung.co.kr

Study Locations

• South Korea
  • Daegu, South Korea
    • Recruiting
    • Kyungbook National university hospital
    • Contact: Seung-hee Won
  • Guri-si, South Korea
    • Not yet recruiting
    • Hanyang University Guri Hospital
    • Contact: JoonHo Choi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gradual titration group	Drug: BR5402A; Subjects take the investigational products once a day; Drug: BR5402B; 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; Other Names: Placebo of BR5402C; Drug: BR5402D; Subjects take the investigational products once a day; Drug: BR5402D-1; Subjects take the investigational products once a day; Other Names: Placebo of BR5402D
Active Comparator: Conventional titration group	Drug: BR5402C; Subjects take the investigational products once a day; Drug: BR5402C-1; Subjects take the investigational products once a day; Other Names: Placebo of BR5402C; Drug: BR5402D; Subjects take the investigational products once a day; Drug: BR5402A-1; Subjects take the investigational products once a day; Other Names: Placebo of BR5402A; Drug: BR5402B-1; Subjects take the investigational products once a day; Other Names: Placebo of BR5402B

What is the study measuring?

Primary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: BR-OLZ-CT-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No