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

Phase 2

Recruiting

• Conditions: Schizophrenia
• Interventions: Drug: BR5402A; Drug: BR5402A-1; Drug: BR5402B; Drug: BR5402B-1; Drug: BR5402C; Drug: BR5402C-1; Drug: BR5402D; Drug: BR5402D-1

• Registration Number: NCT06821945
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gradual titration group	BR5402A	-
Gradual titration group	BR5402B	-
Gradual titration group	BR5402C	-
Gradual titration group	BR5402C-1	-
Conventional titration group	BR5402B-1	-
Gradual titration group	BR5402D	-
Gradual titration group	BR5402D-1	-
Conventional titration group	BR5402A-1	-
Conventional titration group	BR5402C	-
Conventional titration group	BR5402C-1	-
Conventional titration group	BR5402D	-

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

Hanyang University Guri Hospital; 🇰🇷 Guri-si, Korea, Republic of

Kyungbook National university hospital; 🇰🇷 Daegu, Korea, Republic of