Actively Recruiting
A Multi-Center, Randomized, Double-Blind, Parallel-Design Study to Evaluate the Safety and Efficacy of Olanzapine Dose Titration in Schizophrenia
Led by Boryung Pharmaceutical Co., Ltd · Updated on 2025-09-15
120
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating different schedules for adjusting the dose of olanzapine in patients diagnosed with schizophrenia. This Phase 2 clinical trial aims to study how safe and effective a gradual dose increase is compared to a conventional dosing schedule. The study focuses on patients who may benefit from starting with a lower dose of olanzapine based on their medical condition and have had schizophrenia for over one year. Participants are randomly assigned to one of two groups: a gradual titration group or a conventional titration group. Both groups take the investigational products, labeled BR5402A through BR5402D and their variants, once daily. The study is double-blind and conducted at multiple centers, ensuring neither participants nor researchers know the assigned group during the trial. Participants will be monitored over 11 weeks, with evaluations at weeks 1, 2, 3, 5, and 9 to measure changes in schizophrenia symptoms using the Positive and Negative Syndrome Scale (PANSS). Researchers will also track any adverse effects emerging from the treatment during the study period. The trial started in May 2025 and is expected to end in May 2027.
CONDITIONS
Brief Title
A Clinical Trial to Evaluate the Safety and Efficacy of Olanzapine Titration Schedule in Patients With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of schizophrenia according to DSM-5 criteria
- Investigator judgment that a low starting dose of olanzapine is appropriate
- Schizophrenia duration longer than 1 year at screening
You will not qualify if you...
- Diagnosis of schizophrenia spectrum or other psychotic disorders, bipolar disorder, or depressive disorder at screening
- Hospitalization for worsening schizophrenia within 12 weeks before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 11 weeks
Participants take the investigational drug olanzapine once a day according to their assigned titration schedule.
Visits at baseline and Weeks 1, 2, 3, 5, and 9 for assessments
Trial Site Locations
Total: 2 locations
1
Kyungbook National university hospital
Daegu, South Korea
Actively Recruiting
2
Hanyang University Guri Hospital
Guri-si, South Korea
Not Yet Recruiting
Research Team
S
Shin-young Oh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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