NCT06821945 A Clinical Trial to Evaluate the Safety and Efficacy of Olanzapine Titration Schedule in Patients With Schizophrenia
| NCT ID | NCT06821945 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Boryung Pharmaceutical Co., Ltd |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-05-30 |
| Primary Completion | 2027-05 |
Trial Parameters
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Brief Summary
The objective of this clinical trial is to evaluate the safety and efficacy of olanzapine titration schedule in patients with schizophrenia
Eligibility 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)
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