A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (25 and 50 mg/Day) of DVS SR Tablets in Adult Outpatients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 709
- 试验地点
- 1
- 主要终点
- Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)
研究概览
简要总结
The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.
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
- •Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening)
- •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
- •Clinical instability - 25% or greater increase/decrease in HAM-D 17 total score from screening to baseline
- •Significant risk of suicide as assessed by clinician judgement, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply
研究组 & 干预措施
Desvenlafaxine succinate sustained-release 25 mg
干预措施: Desvenlafaxine Succinate Sustained-Release (DVS SR) (Drug)
Desvenlafaxine succinate sustained-release 50 mg
干预措施: Desvenlafaxine Succinate Sustained-Release (DVS SR) (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)
时间窗: Baseline and Week 8 (or ET)
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) at FOT Evaluation (Week 8 or ET)(Week 8 (or ET))
- Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)(Baseline and Week 8 (or ET))
- Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)(Baseline and Week 8 (or ET))
- Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)(Baseline and Week 8 (or ET))
- Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)(Week 8 (or ET))
- Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)(Week 8 (or ET))
- Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)(Week 8 (or ET))
- Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)(Week 8 (or ET))