Recruiting NCT06821945
A Clinical Trial to Evaluate the Safety and Efficacy of Olanzapine Titration Schedule in Patients With Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BR5402A, BR5402A-1, BR5402B, BR5402B-1.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
The objective of this clinical trial is to evaluate the safety and efficacy of olanzapine titration schedule in patients with schizophrenia
Interventions
- Drug BR5402A
Subjects take the investigational products once a day - Drug BR5402A-1
Subjects take the investigational products once a day - Drug BR5402B
Subjects take the investigational products once a day - Drug BR5402B-1
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 - Drug BR5402D
Subjects take the investigational products once a day - Drug BR5402D-1
Subjects take the investigational products once a day
Primary outcome measures
- The mean change of PANSS(Positive and Negative Syndrome Scale) total score [Time frame: 1, 2, 3, 5, 9 weeks from baseline(Visit 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)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
South Korea · 2 centers
- Kyungbook National university hospital — Daegu
- Hanyang University Guri Hospital — Guri-si
Identifiers
NCT: NCT06821945 · BR-OLZ-CT-201