跳至主要内容
临床试验/NCT00535340
NCT00535340终止3 期

An Eight-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Fixed Dose of SR58611A 350 mg Twice a Day in Elderly Patients With Generalized Anxiety Disorder With an Optional Twenty-Four Week Extension

Sanofi5 个研究点 分布在 5 个国家目标入组 55 人开始时间: 2007年3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
Sanofi
入组人数
55
试验地点
5
主要终点
Change from baseline to visit 7 (Day 56) in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score

研究概览

简要总结

The primary objective of this study is to demonstrate the efficacy of SR58611A 350 mg twice a day compared to placebo in elderly patients with Generalized Anxiety Disorder (GAD), as assessed by the 14-item Hamilton Anxiety rating Scale (HAM-A).

Secondary objectives are to evaluate the tolerability and safety of SR58611A in elderly patients with GAD, to evaluate the efficacy of SR58611A compared to placebo on disablility and quality of life in elderly patients with GAD and to evaluate the tolerability and safety of 24 weeks of additional treatment with SR58611A in elderly patients with GAD.

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 (Participant, Investigator)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients diagnosed with Generalized Anxiety Disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and supported by the Mini International Neuropsychiatric Interview (MINI) plus Generalized Anxiety Disorder module

排除标准

  • •Minimum total score of less than 22 on the 14-item HAM-A scale
  • •Total score of 18 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS)
  • •Mini-Mental State Examination (MMSE) score of 22 or less
  • •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

结局指标

主要结局

Change from baseline to visit 7 (Day 56) in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score

次要结局

  • Clinical Global Impression (CGI) Severity of Illness Score
  • Adverse events

研究者

发起方
Sanofi
申办方类型
Industry

研究点 (5)

Loading locations...

相似试验