NCT03395353终止3 期
A Long-term Safety Study of Duloxetine Hydrochloride in the Treatment of Japanese Children and Adolescents With Depressive Disorder
Shionogi1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2018年1月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this long-term study is to evaluate the safety and efficacy of duloxetine hydrochloride in Japanese children and adolescents with depressive disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •a, b) Have a current or previous diagnosis (DSM-5) of the following as judged by the investigator:
- •Neurodevelopmental disorders
- •Schizophrenia spectrum and other psychotic disorders
- •Bipolar and related disorders
- •Trauma and stressor-related disorders
- •Disruptive · Impulse Control · and Conduct disorders
- •a, b) Have a current diagnosis (DSM-5) of the following as judged by the investigator:
- •Obsessive-compulsive and related disorders
- •Anorexia nervosa, Bulimia nervosa, Binge-eating disorder
- •Sleep-wake disorders
- •Neurocognitive disorders
- •Disruptive mood dysregulation disorder
- •a, b) Have personality disorders, in the judgment of the investigator.
研究组 & 干预措施
Duloxetine hydrochloride
Experimental
Duloxetine hydrochloride administered orally.
干预措施: Duloxetine Hydrochloride (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs)
时间窗: Baseline through Week 53
A summary of AEs, ADRs (considered by the investigator) and SAEs is located in the Reported Adverse Events module. An AE was included if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it is consecutive from the preceding study at the initiation of study drug administration in this study.
次要结局
- Pharmacokinetics (PK): Trough Concentration of Duloxetine(Week 4 through Week 50)
- Change From Baseline on the Clinical Global Impression-Severity of Illness (CGI-S)(Baseline, Week 50)
- Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R)(Baseline, Week 50)
研究者
研究点 (1)
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