A Phase 2 Study to Assess Safety and Effectiveness of Different Olanzapine Dosing Schedules in Adults with Schizophrenia

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.

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