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NCT Number: NCT06821945

A 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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kyungbook National university hospital, Daegu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BR5402A

Drug

Subjects take the investigational products once a day

BR5402A-1

Drug

Subjects take the investigational products once a day

Other names: Placebo of BR5402A

BR5402B

Drug

Subjects take the investigational products once a day

BR5402B-1

Drug

Subjects take the investigational products once a day

Other names: Placebo of BR5402B

BR5402C

Drug

Subjects take the investigational products once a day

BR5402C-1

Drug

Subjects take the investigational products once a day

Other names: Placebo of BR5402C

BR5402D

Drug

Subjects take the investigational products once a day

BR5402D-1

Drug

Subjects take the investigational products once a day

Other names: Placebo of BR5402D

Primary outcomes

  1. The mean change of PANSS(Positive and Negative Syndrome Scale) total score

    Time frame: 1, 2, 3, 5, 9 weeks from baseline(Visit 2)

  2. Incidence of treatment-emergent adverse events

    Time frame: From the administration of investigational products prescribed at baseline(Visit 2) to 11 weeks(Visit 8)

Study contacts

Contact information is provided by the study sponsor or research team.

Shin-young Oh

CONTACT

[email protected]

+82+2-708-8000

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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