A Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study of Venlafaxine ER In Children and Adolescent Outpatients With Social Anxiety Disorder

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 293 人开始时间: 1999年12月1日最近更新: 2006年5月19日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 293
主要终点: Final on therapy Social Anxiety Scale-Adolescents and Children (SAS-AC) total score.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

To determine the anxiolytic efficacy, safety, and tolerability of a flexible-dose of venlafaxine extended release (ER) administered for 16 weeks in the treatment of children and adolescent outpatients with social anxiety disorder (generalized) in a placebo-controlled study.

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: 8 Years 至 17 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Male or female outpatient
•8-17 year old
•diagnosis of Social Anxiety Disorder

排除标准

•concomitant psychiatric or medical disorders which interfere with safety or assessment

结局指标

主要结局

Final on therapy Social Anxiety Scale-Adolescents and Children (SAS-AC) total score.

次要结局

Response, defined as a score of 1 (very much improved) or (very improved), on the Clinical Global Impressions-Improvement (CGI-I) scale; Final on therapy Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-AC) total score.

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

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