Evaluating a new dosing schedule of olanzapine for schizophrenia treatment
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
Run by Boryung Pharmaceutical Co., Ltd · NCT06821945 · Data updated 2026-11-12
This study is testing a new way to give olanzapine to see if it helps people with schizophrenia feel better and stay safe.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 2 sites (Daegu and 1 other locations) |
| Status | Recruiting |
| Started | May 30, 2025 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | September 15, 2025 |
| Trial ID | NCT06821945 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients diagnosed with schizophrenia for more than one year who may benefit from a lower initial dose of olanzapine.
✕Probably not a fit
Patients with other psychotic disorders or recent hospitalizations for worsening schizophrenia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the safety and efficacy of a titration schedule for olanzapine in patients diagnosed with schizophrenia. Participants will receive a low dose of olanzapine, which is deemed more appropriate than the standard initial dosing, based on their medical conditions. The study will focus on patients who have had schizophrenia for over a year and will exclude those with other psychotic disorders or recent hospitalizations due to worsening symptoms.
Why it matters
Potential benefit: If successful, this study could lead to a safer and more effective dosing strategy for treating schizophrenia.
How similar studies have gone: While there have been studies on olanzapine, this specific titration approach is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Kyungbook National university hospital
Daegu, South Korea Recruiting -
Hanyang University Guri Hospital
Guri-si, South Korea Not yet recruiting
Study contacts
- Study coordinator: Shin-young Oh
- Email: syoh@boryung.co.kr
- Phone: +82+2-708-8000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.