NCT00236015已完成3 期
A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Gabitril at 4, 8, and 12 mg/Day in the Treatment of Adults With Generalized Anxiety Disorder.
Cephalon104 个研究点 分布在 2 个国家目标入组 880 人开始时间: 2004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
- 已完成
- 发起方
- 入组人数
- 880
- 试验地点
- 104
- 主要终点
- Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to end point in the total score of the HAM-A scale.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (GAD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the DSM-IV-TR criteria for GAD, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., HAM-A, HADS, MADRS and CGI-S).
排除标准
- •Have been previously unresponsive to two or more adequate courses of pharmacological treatment for GAD
- •Have been diagnosed with any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months
- •Have been diagnosed with any eating disorder within the past six months
- •Have any history of OCD, psychotic disorder, bipolar disorder or antisocial personality disorder
- •Have any history of alcohol or substance abuse within 3 months of screening
- •Have any history of seizures, including febrile seizures
- •Have any history of head trauma associated with loss of consciousness within the past 15 years
结局指标
主要结局
Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to end point in the total score of the HAM-A scale.
次要结局
- Assessment of proportion of responders and patients in remission according to HAM-A scores and CGI ratings by visit, assessment of the safety and tolerability in patients with GAD
研究者
研究点 (104)
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