Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 19 and up

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.

More Schizophrenia trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages19 Years and up
SexAll
Enrollment120 (estimated)
SponsorBoryung Pharmaceutical Co., Ltd
Industry-sponsored
Locations2 sites (Daegu and 1 other locations)
StatusRecruiting
StartedMay 30, 2025
Main results expectedMay 2027
Study endsMay 2027
Registry record updatedSeptember 15, 2025
Trial IDNCT06821945 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.