A Multicenter, Double-blind, Placebo- and Active-Controlled Parallel-Group Evaluation of the Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 473
- 试验地点
- 59
- 主要终点
- Change in 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 evaluate the efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female outpatients between 7-17 years of age
- •Primary diagnosis of Major Depressive Disorder (MDD)
- •Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater
- •Clinical Global Impressions-Severity (CGI-S) score of 4 or greater
排除标准
- •Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder other than major depressive disorder (MDD) that is the primary focus of treatment.
- •History of suicidal behavior, or requires precaution against suicide
- •Not generally healthy medical condition
- •Seizure disorder
研究组 & 干预措施
Vilazodone
Vilazodone tablets, 5mg, 10mg and 20mg. Oral administration, once per day.
干预措施: Vilazodone (Drug)
Placebo
Dose-matched placebo tablets or capsules, oral administration, once per day.
干预措施: Placebo (Drug)
Fluoxetine
Fluoxetine capsules, 10mg and 20 mg. Oral administration, once per day.
干预措施: Fluoxetine (Drug)
结局指标
主要结局
Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
时间窗: From Baseline to Week 8
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.
次要结局
- Change in Clinical Global Impressions-Severity (CGI-S) Score(From Baseline to Week 8)