NCT01844115已完成3 期
A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.
Forest Laboratories36 个研究点 分布在 1 个国家目标入组 415 人开始时间: 2013年4月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 415
- 试验地点
- 36
- 主要终点
- Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatient, 18-70 years of age
- •Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder
- •Minimum score of 20 on Hamilton Rating Scale for Anxiety
排除标准
- •Women who are pregnant or who will be breastfeeding during the study
- •Patients with a history of:
- •Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode
- •Any depressive episode with psychotic or catatonic features
- •Panic disorder with or without agoraphobia
研究组 & 干预措施
Placebo
Placebo Comparator
Dose-matched placebo tablets, oral administration
干预措施: Placebo (Drug)
Vilazodone
Experimental
Vilazodone tablets, oral administration
干预措施: Vilazodone (Drug)
结局指标
主要结局
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
时间窗: Baseline to Week 8
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
次要结局
- Change From Baseline in the Sheehan Disability Scale (SDS) Total Score(Baseline to Week 8)
研究者
研究点 (36)
Loading locations...
相似试验
已完成
3 期
Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety DisorderGeneralized Anxiety DisorderNCT01766401Forest Laboratories402
已完成
3 期
Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive DisorderMajor Depressive DisorderNCT01878292Forest Laboratories529
已完成
3 期
Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety DisorderGeneralized Anxiety DisorderNCT01629966Forest Laboratories680
已完成
3 期
Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)Major Depressive DisorderNCT02372799Forest Laboratories473
已完成
2 期
Double-Blind Treatment of Major Depressive Disorder With VilazodoneMajor Depressive DisorderNCT01742832University of Chicago79