NCT06821945招募中2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The mean change of PANSS(Positive and Negative Syndrome Scale) total score
研究概览
简要总结
The objective of this clinical trial is to evaluate the safety and efficacy of olanzapine titration schedule in patients with schizophrenia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Gradual titration group
Experimental
干预措施: BR5402A (Drug)
Gradual titration group
Experimental
干预措施: BR5402B (Drug)
Gradual titration group
Experimental
干预措施: BR5402C (Drug)
Gradual titration group
Experimental
干预措施: BR5402C-1 (Drug)
Gradual titration group
Experimental
干预措施: BR5402D (Drug)
Gradual titration group
Experimental
干预措施: BR5402D-1 (Drug)
Conventional titration group
Active Comparator
干预措施: BR5402A-1 (Drug)
Conventional titration group
Active Comparator
干预措施: BR5402B-1 (Drug)
Conventional titration group
Active Comparator
干预措施: BR5402C (Drug)
Conventional titration group
Active Comparator
干预措施: BR5402C-1 (Drug)
Conventional titration group
Active Comparator
干预措施: BR5402D (Drug)
结局指标
主要结局
The mean change of PANSS(Positive and Negative Syndrome Scale) total score
时间窗: 1, 2, 3, 5, 9 weeks from baseline(Visit 2)
Incidence of treatment-emergent adverse events
时间窗: From the administration of investigational products prescribed at baseline(Visit 2) to 11 weeks(Visit 8)
次要结局
未报告次要终点
研究者
研究点 (2)
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