A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 680
- 试验地点
- 37
- 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 and female, 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 (GAD)
- •Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)
排除标准
- •Women who are pregnant, women who will be breastfeeding during the study and women of childbearing potential who are not practicing a reliable method of birth control
- •History of meeting DSM-IV-TR criteria for any of the following:
- •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
- •Obsessive-compulsive disorder
- •Schizophrenia, schizoaffective, or other psychotic disorder
- •Bulimia or anorexia nervosa
- •Presence of borderline personality disorder or antisocial personality disorder
- •Mental retardation, dementia, amnesia, or other significant cognitive disorders
- •Patients who are considered a suicide risk
研究组 & 干预措施
Placebo
Dose-matched placebo one per day, oral administration
干预措施: Placebo (Drug)
Vilazadone 20mg
Vilazodone 20mg once per day, oral administration.
干预措施: Vilazodone (Drug)
Vilazodone 40mg
Vilazodone 40mg once per day, 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)