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

NCT ID: NCT06821945

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-30

Study Completion Date

2027-05-31

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Gradual titration group

Group Type EXPERIMENTAL

BR5402A

Intervention Type DRUG

Subjects take the investigational products once a day

BR5402B

Intervention Type DRUG

Subjects take the investigational products once a day

BR5402C

Intervention Type DRUG

Subjects take the investigational products once a day

BR5402C-1

Intervention Type DRUG

Subjects take the investigational products once a day

BR5402D

Intervention Type DRUG

Subjects take the investigational products once a day

BR5402D-1

Intervention Type DRUG

Subjects take the investigational products once a day

Conventional titration group

Group Type ACTIVE_COMPARATOR

BR5402A-1

Intervention Type DRUG

Subjects take the investigational products once a day

BR5402B-1

Intervention Type DRUG

Subjects take the investigational products once a day

BR5402C

Intervention Type DRUG

Subjects take the investigational products once a day

BR5402C-1

Intervention Type DRUG

Subjects take the investigational products once a day

BR5402D

Intervention Type DRUG

Subjects take the investigational products once a day

Interventions

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BR5402A

Subjects take the investigational products once a day

Intervention Type DRUG

BR5402A-1

Subjects take the investigational products once a day

Intervention Type DRUG

BR5402B

Subjects take the investigational products once a day

Intervention Type DRUG

BR5402B-1

Subjects take the investigational products once a day

Intervention Type DRUG

BR5402C

Subjects take the investigational products once a day

Intervention Type DRUG

BR5402C-1

Subjects take the investigational products once a day

Intervention Type DRUG

BR5402D

Subjects take the investigational products once a day

Intervention Type DRUG

BR5402D-1

Subjects take the investigational products once a day

Intervention Type DRUG

Other Intervention Names

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Placebo of BR5402A Placebo of BR5402B Placebo of BR5402C Placebo of BR5402D

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kyungbook National university hospital

Daegu, , South Korea

Site Status RECRUITING

Hanyang University Guri Hospital

Guri-si, , South Korea

Site Status NOT_YET_RECRUITING

Countries

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South Korea

Central Contacts

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Shin-young Oh

Role: CONTACT

+82+2-708-8000

Facility Contacts

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Seung-hee Won

Role: primary

JoonHo Choi

Role: primary

Other Identifiers

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BR-OLZ-CT-201

Identifier Type: -

Identifier Source: org_study_id

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