A Clinical Trial to Evaluate the Safety and Efficacy of Olanzapine Titration Schedule in Patients With Schizophrenia
Recruiting · NCT06821945 · Interventional (participants receive a specific treatment) · Lead sponsor: Boryung Pharmaceutical Co., Ltd
View the official record on ClinicalTrials.gov →Interventions studied
BR5402ABR5402A-1BR5402BBR5402B-1BR5402CBR5402C-1BR5402DBR5402D-1
What this trial is about
The objective of this clinical trial is to evaluate the safety and efficacy of olanzapine titration schedule in patients with schizophrenia
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed.
- Kyungbook National university hospital - Daegu, South Korea
- Hanyang University Guri Hospital - Guri-si, South Korea