A Multi-center, Randomized, Double-blind, Double-simulation, Duloxetine Hydrochloride Enteric-coated Positive-control Phase III Study of Desvenlafaxine Succinate Sustained-Release in the Treatment of Major Depressive Disorder.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
研究概览
简要总结
The primary purpose of this study is to evaluate if the effectiveness of desvenlafaxine succinate sustained-release tablet (50 mg/day) used for 8 weeks is not inferior to duloxetine hydrochloride enteric-coated capsule (60 mg/day) in adult patients with major depressive disorder.
详细描述
This is a multicenter study to evaluate if the effectiveness of desvenlafaxine succinate sustained-release tablet (50 mg/day) used for 8 weeks is not inferior to duloxetine hydrochloride enteric-coated capsule (60 mg/day) in adult patients with major depressive disorder. A total of 400 subjects will be randomly allocated to experimental arm (desvenlafaxine succinate sustained-release tablet) and active comparator arm (duloxetine hydrochloride enteric-coated capsule) in a 1:1 ratio.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 ≤ age ≤ 65 years old, male or female;
- •Outpatients and inpatients who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and Neuropsychiatric Interview5.0.0 (MINI5.0.0) for a primary diagnosis of Major Depressive Disorder(MDD), single or recurrent episode and measured by the Mini-International Neuropsychiatric Interview5.0.0 (MINI5.0.0) as active stage.
- •Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of >= 18.
排除标准
- •Hamilton Rating Scale for Anxiety (HAM-A) total score of >
- •Refractory depression: Ineffective after adequate treatment with two or more antidepressants.
- •Current or previous diagnosis of Axis I with DSM-IV other than depression.
- •Significant risk of suicide based on clinical judgment or HAM-D 17, Suicide attempt in the past 6 months.
- •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
Desvenlafaxine Succinate Sustained-Release
干预措施: Desvenlafaxine Succinate Sustained-Release Tablet , Duloxetine Hydrochloride Enteric-coated Capsule Placebo (Drug)
Desvenlafaxine Succinate Sustained-Release
干预措施: Duloxetine Hydrochloride Enteric-coated Capsule Placebo (Drug)
Duloxetine Hydrochloride Enteric-coated
干预措施: Desvenlafaxine Succinate Sustained-Release Tablet Placebo, Duloxetine Hydrochloride Enteric-coated Capsule (Drug)
Duloxetine Hydrochloride Enteric-coated
干预措施: Duloxetine Hydrochloride Enteric-coated Capsule (Drug)
结局指标
主要结局
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
时间窗: Baseline to Week 8
Hamilton Rating Scale for Depression, 17-item is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline.
次要结局
- Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate(Baseline to Week 8)
- Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate(Baseline to Week 8)
- Change From Baseline on the Hamilton Rating Scale for Anxiety (HAM-A) Total Score(Baseline to Week 8)
- Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)(Baseline to Week 8)
- Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)(Baseline to Week 8)
- Change From Baseline on the Visual Analog Scale (VAS) for Pain(Baseline to Week 8)