NCT01977378Unknown2 期
A Double-Blind,Venlafaxine-Controlled Study of Efficacy and Safety of Sustained-Release Desvenlafaxine Hydrochloride in the Treatment of Major Depressive Disorder
Jiangsu Hansoh Pharmaceutical Co., Ltd.6 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17)
研究概览
简要总结
A multicenter, 10-week study to evaluate the efficacy and safety of Sustained-Release Desvenlafaxine Hydrochloride versus Sustained-Release venlafaxine Hydrochloride in adult 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
- Double (Participant, Investigator)
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
- •Adult with primary diagnosis of Major Depressive Disorder
- •Aged from 18 years to 65 years
- •A primary diagnosis of Major Depressive Disorder based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features
- •Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of ≧ 20
- •Clinical Global Impressions Scale-Severity (CGI-S) score of ≧4
排除标准
- •Known hypersensitivity to desvenlafaxine or venlafaxine
- •Significant risk of suicide based on clinical judgment
- •Women who were pregnant,breast-feeding,or planning to become pregnant during study
- •Had a history of seizure disorder
- •History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs
- •Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
研究组 & 干预措施
Sustained-Release Desvenlafaxine Hydrochloride
Experimental
50-100mg/d
干预措施: Sustained-Release Desvenlafaxine Hydrochloride (Drug)
Sustained-Release Venlafaxine Hydrochloride
Active Comparator
75-225mg/d
干预措施: Sustained-Release Venlafaxine Hydrochloride (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)
时间窗: Baseline to Week 10
次要结局
- Change From Baseline on the Clinical Global Impression Scale(Baseline to Week 10)
- Number of Participants in Remission Based on the HAM-D17 at Week 10(Baseline to Week 10)
- Change From Baseline in Clinical Global Impression-Improvement (CGI-I) Scale(Baseline to Week 10)
- Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 10(Baseline to Week 10)
- Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS)(Baseline to Week 10)
- Change From Baseline on the Visual Analogue Scale-Pain Intensity (VAS-PI)(Baseline to Week 10)
研究者
研究点 (6)
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