NCT02436239已完成3 期
An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
Forest Laboratories55 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2015年5月2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
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 55
- 主要终点
- Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE)
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone for the treatment of MDD in pediatric outpatients (7-17 years).
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
- 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 betw een 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, Fourth Edition, Text Revision based diagnosis of an Axis I disorder other than MDD that is the primary focus of treatment (de novo patients only)
- •History of suicidal behavior, or requires precaution against suicide
- •Not generally healthy medical condition
- •Seizure disorder
研究组 & 干预措施
Vilazodone
Experimental
干预措施: Vilazodone (Drug)
结局指标
主要结局
Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE)
时间窗: Visit 1 (Week -1) to up to Visit 16 (Week 26)
The number of Participants who experienced a treatment emergent adverse events during the 27 week period from screening to the end of the open-label treatment period
次要结局
- Change From Baseline in the CDRS-R Total Score(Baseline (Week 0) to Week 26)
- Change From Baseline in the CGI-S Score(Baseline (Week 0) to Week 26)
- Change From Baseline in Clinical Global Impressions-Improvement (CGI-I)(Baseline (Week 0) to Week 26)
研究者
研究点 (55)
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