A Double-blind, Efficacy and Safety Study of Duloxetine Hydrochloride Versus Placebo in the Treatment of Japanese Children and Adolescents With Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) Total Score
研究概览
简要总结
The purpose of this study is to determine the efficacy of duloxetine hydrochloride versus placebo in the treatment of Japanese children and adolescents with depressive disorder.
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
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with Major Depressive Disorder or persistent depressive disorder and completely meet the criteria of major depressive episode as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) ver.7.0.
- •Participants whose incipient age of depression was ≥7 years old.
- •Total score of CDRS-R is ≥40 and CGI-S score is ≥4 at both screening and baseline.
排除标准
- •Have remarkable response to psycho-education (defined as >30% decrease in the total score of CDRS-R between screening and baseline).
- •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
- •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
- •Have personality disorders, in the judgement of the investigator.
研究组 & 干预措施
Duloxetine Hydrochloride
Duloxetine hydrochloride given orally.
干预措施: Duloxetine Hydrochloride (Drug)
Placebo
Placebo given orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) Total Score
时间窗: Baseline, Week 6
Change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) total score. CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including treatment group, observation time-points, and interaction between treatment group and observation time-points as fixed effects, and baseline CDRS-R total score and age as covariates.
次要结局
- Percentage of Participants With Total Children's Depression Rating Scale-Revised (CDRS-R) Score ≤ 28(Baseline, Week 6)
- Percentage of Participants Whose Children's Depression Rating Scale-Revised (CDRS-R) Total Score Decreased by More Than 30% From Baseline(Baseline, Week 6)
- Percentage of Participants Whose CDRS-R Total Score Decreased by More Than 50% From Baseline(Baseline, Week 6)
- Change From Baseline on Clinical Global Impression-Severity (CGI-S)(Baseline, Week 6)