SchizophreniaPhase 2NCT06821945
A Clinical Trial to Evaluate the Safety and Efficacy of Olanzapine Titration Schedule in Patients With Schizophrenia
A Phase 2 study testing BR5402A, BR5402A-1 and BR5402B in people with Schizophrenia, run by Boryung Pharmaceutical Co., Ltd at 2 sites in South Korea.
Trial summary
The objective of this clinical trial is to evaluate the safety and efficacy of olanzapine titration schedule in patients with schizophrenia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- BR5402A, BR5402A-1 and BR5402B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 30 May 2025to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Kyungbook National university hospital
Daegu
Seung-hee Won
- Not yet recruiting
Hanyang University Guri Hospital
Guri-si
JoonHo Choi
About this study
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
The objective of this clinical trial is to evaluate the safety and efficacy of olanzapine titration schedule in patients with schizophrenia
- Conditions
- Schizophrenia
- Being tested
- BR5402A, BR5402A-1, BR5402B, BR5402B-1, BR5402C
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR5402ADrug
Subjects take the investigational products once a day
BR5402A-1Drug
Also called Placebo of BR5402A
Subjects take the investigational products once a day
BR5402BDrug
Subjects take the investigational products once a day
BR5402B-1Drug
Also called Placebo of BR5402B
Subjects take the investigational products once a day
BR5402CDrug
Subjects take the investigational products once a day
BR5402C-1Drug
Also called Placebo of BR5402C
Subjects take the investigational products once a day
BR5402DDrug
Subjects take the investigational products once a day
BR5402D-1Drug
Also called Placebo of BR5402D
Subjects take the investigational products once a day
| Study group | Role | What they receive |
|---|---|---|
| Gradual titration group | Experimental | Not described Receives: Drug: BR5402A; Drug: BR5402B; Drug: BR5402C; Drug: BR5402C-1; Drug: BR5402D; Drug: BR5402D-1 |
| Conventional titration group | Active comparator | Not described Receives: Drug: BR5402A-1; Drug: BR5402B-1; Drug: BR5402C; Drug: BR5402C-1; Drug: BR5402D |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change of PANSS(Positive and Negative Syndrome Scale) total score
Measured: 1, 2, 3, 5, 9 weeks from baseline(Visit 2)
Incidence of treatment-emergent adverse events
Measured: From the administration of investigational products prescribed at baseline(Visit 2) to 11 weeks(Visit 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start30 May 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821945
- Sponsor's protocol ID
- BR-OLZ-CT-201
- Status last verified
- Sep 2025
- First submitted
- 6 Feb 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06821945
- Acronym / sponsor ID
- BR-OLZ-CT-201
- Conditions
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial is to evaluate the safety and efficacy of olanzapine titration schedule in patients with schizophrenia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gradual titration group | Experimental | Drug: BR5402A, Drug: BR5402B, Drug: BR5402C, Drug: BR5402C-1, Drug: BR5402D, Drug: BR5402D-1 |
| Conventional titration group | Active comparator | Drug: BR5402A-1, Drug: BR5402B-1, Drug: BR5402C, Drug: BR5402C-1, Drug: BR5402D |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BR5402ASubjects take the investigational products once a day | Drug | Gradual titration group |
| BR5402A-1Also: Placebo of BR5402ASubjects take the investigational products once a day | Drug | Conventional titration group |
| BR5402BSubjects take the investigational products once a day | Drug | Gradual titration group |
| BR5402B-1Also: Placebo of BR5402BSubjects take the investigational products once a day | Drug | Conventional titration group |
| BR5402CSubjects take the investigational products once a day | Drug | Conventional titration group, Gradual titration group |
| BR5402C-1Also: Placebo of BR5402CSubjects take the investigational products once a day | Drug | Conventional titration group, Gradual titration group |
| BR5402DSubjects take the investigational products once a day | Drug | Conventional titration group, Gradual titration group |
| BR5402D-1Also: Placebo of BR5402DSubjects take the investigational products once a day | Drug | Gradual titration group |
Primary outcome
The mean change of PANSS(Positive and Negative Syndrome Scale) total score
Time frame: 1, 2, 3, 5, 9 weeks from baseline(Visit 2)
Incidence of treatment-emergent adverse events
Time frame: From the administration of investigational products prescribed at baseline(Visit 2) to 11 weeks(Visit 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BR5402A, BR5402A-1 and BR5402B in people with Schizophrenia, run by Boryung Pharmaceutical Co., Ltd at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shin-young Oh (+82+2-708-8000, syoh@boryung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change of PANSS(Positive and Negative Syndrome Scale) total score (time frame: 1, 2, 3, 5, 9 weeks from baseline(Visit 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.