NCT00150306终止3 期
A Multicenter, 10-Week, Randomized, Double-Blind Study Of Sertraline And Placebo In Children And Adolescents With Posttraumatic Stress Disorder (PTSD)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.24 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2002年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 160
- 试验地点
- 24
- 主要终点
- The primary efficacy parameter is the University of California at Los Angeles Post-Traumatic Stress Disorder Index for DSM-IV (UCLA PTSD-I).
研究概览
简要总结
To evaluate the safety and efficacy of sertraline compared to placebo in children and adolescents (6 to 17 years of age) who are outpatients with Posttraumatic Stress Disorder.
详细描述
This study was terminated on July 11, 2007. The results of the primary endpoint analysis at the interim showed that the Zoloft group was not significantly different than the placebo on the primary endpoint and therefore the decision was made to terminate the trial. The decision to terminate the trial was not based on any safety concerns.
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
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be from 6 to 17 years of age and will have a maximum age of 17 at the Baseline Visit of the study.
- •Subjects must have a diagnosis of Posttraumatic Stress Disorder as defined by DSM-IV and determined by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
排除标准
- •Subjects whose trauma is ongoing, or who are living in the same home as their abuser, or who are expected to participate in litigation related to their trauma during the course of the study will be excluded from participation.
- •Subjects who are likely to or are at high risk for experiencing re-exposure to their index trauma.
结局指标
主要结局
The primary efficacy parameter is the University of California at Los Angeles Post-Traumatic Stress Disorder Index for DSM-IV (UCLA PTSD-I).
次要结局
- Secondary efficacy measures include
- Child Stress Disorder Checklist (CSDC)
- Clinical Global Impression Severity (CGI-S)
- Clinical Global Impression Improvement (CGI-I)
- Children's Depression Rating Scale - Revised edition (CDRS-R)
研究者
研究点 (24)
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