Evaluating a new dosing schedule of olanzapine for schizophrenia treatment
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
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 |
| Enrollment | 120 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 2 sites (Daegu and 1 other locations) |
| Trial ID | NCT06821945 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with schizophrenia for more than one year who may benefit from a lower initial dose of olanzapine.
Not a fit: Patients with other psychotic disorders or recent hospitalizations for worsening schizophrenia may not benefit from this study.
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 performed: While there have been studies on olanzapine, this specific titration approach is relatively novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Daegu and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.