A Multicenter, Randomized, Double-blind, Paroxetine-referenced, Parallel-group Study to Evaluate the Safety, Efficacy, and Tolerability of 3 Fixed Doses (50mg, 100mg, AND 200mg) of Desvenlafaxine Succinate Sustained-release Tablets in Adult Outpatients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 807
- 主要终点
- Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)
研究概览
简要总结
This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.
详细描述
The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient men and women at least 18 years of age.
- •Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features.
- •Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.
排除标准
- •Treatment with DVS SR at any time in the past.
- •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.
研究组 & 干预措施
A
DVS SR 50mg/day
干预措施: DVS SR (Drug)
B
DVS SR 100mg/day
干预措施: DVS SR (Drug)
C
DVS SR 200mg/day
干预措施: DVS SR (Drug)
D
Paroxetine 20mg/day
干预措施: Paroxetine (Drug)
结局指标
主要结局
Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)
时间窗: 8 weeks
HAM-D17 is 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
- Clinical Global Impressions Scale-Improvement (CGI-I) Scores(8 weeks)
- Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores(8 weeks)
- Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline(Baseline and 8 weeks)
- Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline(8 weeks)
- Covi Anxiety Scale Score Mean Change From Baseline(8 weeks)
- Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline(8 weeks)