NCT01741142终止2 期
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of ABT-436 in Major Depressive Disorder
AbbVie (prior sponsor, Abbott)18 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2012年1月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 18
- 主要终点
- Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.
研究概览
简要总结
The purpose is to study the efficacy and safety of ABT-436 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a primary Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision diagnosis of major depressive disorder without psychotic features
- •No current antidepressant treatment within 7 half-lives or 2 weeks, whichever is longer, prior to Day minus
- •Can safely be treated on an outpatient basis.
- •A condition of general good physical health.
- •Surgically sterile, using a highly effective method of birth control or (if female) at least 1 year post menopausal.
排除标准
- •History of hypersensitivity, intolerance or adverse reaction to escitalopram that led to discontinuation, or hypersensitivity to citalopram. History of serotonin syndrome.
- •Inadequate response to more than two different antidepressant medications during the current major depressive episode.
- •History of electroconvulsive therapy, vagal nerve stimulation or deep brain stimulation.
- •History of transcranial magnetic stimulation during the current major depressive episode.
- •Psychotherapy that has not been ongoing for at least 3 months prior to Day minus 1.
研究组 & 干预措施
ABT-436
Experimental
Subject receiving ABT-436
干预措施: ABT-436 (Drug)
Escitalopram
Active Comparator
Subject receiving escitalopram.
干预措施: Escitalopram (Drug)
Placebo
Placebo Comparator
Subject receiving placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.
时间窗: Week 6
Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.
次要结局
- Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale.(Week 6)
研究者
研究点 (18)
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