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

Last updated: February 11, 2025
Sponsor: Boryung Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Psychosis

Treatment

BR5402C

BR5402D-1

BR5402C-1

Clinical Study ID

NCT06821945
BR-OLZ-CT-201
  • Ages > 19
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Of patients with schizophrenia in accordance with DSM(Diagnostic and StatisticalManual of Mental Disorders)-5 diagnostic criteria, who are judged thatadministration of low dose is more appropriate than initial recommended dose orstandard titration dose of olanzapine to consider medical conditions by investigator

  • Patients with the duration of schizophrenia for more than 1 year at screeningvisit(Visit 1)

Exclusion

Exclusion Criteria:

  • Patients diagnosed schizophrenia spectrum and other psychotic disorder(e.g.schizoaffective disorder, etc.), bipolar disorder, depressive disorder, etc., inaccordance with DSM(Diagnostic and Statistical Manual of Mental Disorders)-5diagnostic criteria at screening visit(Visit 1)

  • Patients with a history of hospitalization for worsening schizophrenia within 12weeks at screening visit(Visit 1)

Study Design

Total Participants: 120
Treatment Group(s): 8
Primary Treatment: BR5402C
Phase: 2
Study Start date:
February 01, 2025
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • Kyungbook National university hospital

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Hanyang University Guri Hospital

    Guri-si,
    Korea, Republic of

    Site Not Available

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