NCT01573598已完成4 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study With Vilazodone in Patients With Major Depressive Disorder
Forest Laboratories75 个研究点 分布在 4 个国家目标入组 1,219 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,219
- 试验地点
- 75
- 主要终点
- Time to first relapse during the double-blind treatment phase
研究概览
简要总结
Safety and Efficacy of Vilazodone in Major Depressive Disorder
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
- •Men and women, 18-70 years of age
- •Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
- •The patient's current major depressive episode must be at least 8 weeks and no longer than 18 months in duration
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
- •Patients with a history of meeting DSM-IV-TR criteria for:
- •any manic, 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; h. mental retardation, dementia, amnesia, or other cognitive disorders
- •Patients who are considered a suicide risk
研究组 & 干预措施
Placebo
Placebo Comparator
Dose-matched placebo capsules, oral administration
干预措施: Placebo (Drug)
Vilazodone 20mg
Experimental
Vilazodone tablets, 20 mg per day, oral administration
干预措施: Vilazodone (Drug)
Vilazodone 40mg
Experimental
Vilazodone tablets, 40 mg per day, oral administration
干预措施: Vilazodone (Drug)
结局指标
主要结局
Time to first relapse during the double-blind treatment phase
时间窗: Number of days from the randomization date to the relapse date, up to 28 weeks.
次要结局
未报告次要终点
研究者
研究点 (75)
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