NCT00824291已完成3 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 437 人开始时间: 2009年2月最近更新:
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
- 437
- 主要终点
- Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12
研究概览
简要总结
This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.
- •Employed for 20 hours or more for a minimum of 1 month prior to baseline.
- •Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.
排除标准
- •Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.
- •Treatment-resistant defined as any of the following failed treatments in the past 3 years: 3 or more previous adequate trials of >=2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).
- •Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
- •Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.
研究组 & 干预措施
1
Placebo Comparator
干预措施: desvenlafaxine succinate sustained release (Drug)
2
Experimental
干预措施: Genotyping (Genetic)
结局指标
主要结局
Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12
时间窗: At Baseline and Week 12.
HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.
次要结局
- Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12(At Baseline and Week 12.)
- Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12(At Baseline and Week 12.)
- Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12(At Baseline and Week 12.)
- Change From Baseline on Work and Activities Item of HAM-D17 at Week 12(At Baseline and Week 12.)
- Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12(At Baseline and Week 12.)
- Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12(At Baseline and Week 12.)
- Change From Baseline on Stress and Social Support Scales at Week 12(At Baseline and Week 12.)
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