New dosing strategy for schizophrenia drug aims to cut side effects
NCT ID NCT06821945
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests different ways to start taking olanzapine, a common schizophrenia medication, to see if a slower dose increase can reduce side effects while still controlling symptoms. About 120 adults with schizophrenia will receive one of several dosing schedules or a placebo. The goal is to find a safer, effective starting plan.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Olanzapine
- What this could lead to
- If successful, this could lead to a safer way to start olanzapine treatment for schizophrenia, reducing side effects while still controlling symptoms.
- What could go wrong
- This is an early phase 2 trial with only 120 participants, so results may not apply to everyone. Different dosing schedules may not improve safety or effectiveness as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hanyang University Guri Hospital
NOT_YET_RECRUITINGGuri-si, South Korea
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Kyungbook National university hospital
RECRUITINGDaegu, South Korea
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Other studies related to the condition(s) this trial covers.
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- New schizophrenia drug targets brain glutamate, not dopamine
- New drug candidate takes aim at schizophrenia symptoms
- New schizophrenia drug goes Head-to-Head with standard antipsychotics in Long-Term trial
- Five-Year safety check for experimental schizophrenia drug
- A shot every few weeks? new drug tested for schizophrenia