NCT00384033已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Duloxetine-Referenced, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50mg, 100mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder
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
- Pfizer
- 入组人数
- 638
- 试验地点
- 1
- 主要终点
- Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.
- •Depressive symptoms for at least 30 days before the screening visit.
- •Outpatient men and women at least 18 years of age.
排除标准
- •Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
- •Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
- •Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.
研究组 & 干预措施
Desvenlafaxine succinate sustained-release 50 mg
Experimental
干预措施: Desvenlafaxine Succinate Sustained-Release (DVS SR) (Drug)
Desvenlafaxine succinate sustained-release 100 mg
Experimental
干预措施: Desvenlafaxine Succinate Sustained-Release (DVS SR) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Duloxetine 60mg
Other
Active control to assess assay sensitivity
干预措施: Duloxetine 60 mg/day (Drug)
结局指标
主要结局
Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation
时间窗: Baseline and Week 8 or FOT
HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0 = none/absent and 4 = most severe, for a maximum total score of 50.
次要结局
- Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation(Week 8 or FOT)
- Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation(Baseline and Week 8 or FOT)
- Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation(Baseline and Week 8 or FOT)
- Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation(Baseline and Week 8 or FOT)
- Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation(Baseline and Week 8 or FOT)
- Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation(Baseline and Week 8 or FOT)
- Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation(Baseline and Week 8 or FOT)
- Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation(Baseline and Week 8 or FOT)
研究者
研究点 (1)
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