RecruitingPhase 2NCT06821945

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

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


Sponsor

Boryung Pharmaceutical Co., Ltd

Enrollment

120 participants

Start Date

May 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial evaluates a gradual (titrated) low-dose starting schedule of olanzapine, an antipsychotic medication, for people with schizophrenia where a lower-than-usual starting dose is considered safer by the treating doctor. **You may be eligible if...** - You have been diagnosed with schizophrenia (according to DSM-5 criteria) for more than 1 year - Your doctor judges that a lower starting dose of olanzapine is more appropriate for you than the standard dose **You may NOT be eligible if...** - You have a different psychotic or mood disorder (such as schizoaffective disorder, bipolar disorder, or depression) - You have serious medical conditions that contraindicate olanzapine use - You are pregnant or breastfeeding - You have had no response to olanzapine in the past Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBR5402A

Subjects take the investigational products once a day

DRUGBR5402A-1

Subjects take the investigational products once a day

DRUGBR5402B

Subjects take the investigational products once a day

DRUGBR5402B-1

Subjects take the investigational products once a day

DRUGBR5402C

Subjects take the investigational products once a day

DRUGBR5402C-1

Subjects take the investigational products once a day

DRUGBR5402D

Subjects take the investigational products once a day

DRUGBR5402D-1

Subjects take the investigational products once a day


Locations(2)

Kyungbook National university hospital

Daegu, South Korea

Hanyang University Guri Hospital

Guri-si, South Korea

View Full Details on ClinicalTrials.gov

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NCT06821945


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