Extracellular Vesicles as Predictors of Antidepressant Outcomes in Pediatric Anxiety (EV-SOPRANO)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2
研究概览
简要总结
A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.
详细描述
Randomized, double-blind, placebo-controlled trial of an evidence-based antidepressant, sertraline, in youth (N=120) with generalized, separation and/or social anxiety disorders, seeks to evaluate the predictive value of plasma EV signatures. Patients will be randomized to sertraline (25-200 mg/day) or placebo (3:1) and total plasma EVs will be collected at baseline and serially during the course of the 12-week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double Blind
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
sertraline
90 patients will be randomized to sertraline
干预措施: sertraline (Drug)
Placebo
30 patient will be randomized to placebo
干预措施: sertraline (Drug)
结局指标
主要结局
Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2
时间窗: Week 12
Primary response outcome will be treatment response based on patients having attained a score on the Clinical Global Impression-Improvement Scale ≤ 2 at Week 12 or Last-Observation-Carried-Forward (LOCF).
次要结局
未报告次要终点
研究者
Jeffrey Strawn, MD
Associate professor
University of Cincinnati