A Clinical Trial to Evaluate the Safety and Efficacy of Olanzapine Titration Schedule in Patients With Schizophrenia
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
1 other identifier
interventional
120
1 country
2
Brief Summary
The objective of this clinical trial is to evaluate the safety and efficacy of olanzapine titration schedule in patients with schizophrenia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 schizophrenia
Started May 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2025
CompletedFirst Posted
Study publicly available on registry
February 12, 2025
CompletedStudy Start
First participant enrolled
May 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
September 15, 2025
September 1, 2025
1.9 years
February 6, 2025
September 11, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
The mean change of PANSS(Positive and Negative Syndrome Scale) total score
1, 2, 3, 5, 9 weeks from baseline(Visit 2)
Incidence of treatment-emergent adverse events
From the administration of investigational products prescribed at baseline(Visit 2) to 11 weeks(Visit 8)
Study Arms (2)
Gradual titration group
EXPERIMENTALConventional titration group
ACTIVE COMPARATORInterventions
Subjects take the investigational products once a day
Subjects take the investigational products once a day
Subjects take the investigational products once a day
Subjects take the investigational products once a day
Subjects take the investigational products once a day
Subjects take the investigational products once a day
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kyungbook National university hospital
Daegu, South Korea
Hanyang University Guri Hospital
Guri-si, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2025
First Posted
February 12, 2025
Study Start
May 30, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share