A Phase IV, Multicenter, Randomized, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy of 2 Fixed Doses (50 and 100 mg/Day) of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 924
- 试验地点
- 57
- 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
A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients 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
- •Male or female outpatients aged 18 years or older who are fluent in written and spoken English.
- •A primary diagnosis of MDD 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.
- •A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no more than a 4-point improvement from screening to baseline.
排除标准
- •Significant risk of suicide based on clinical judgment.
- •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.
- •Current generalized anxiety disorder, panic disorder, or social anxiety 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
desvenlafaxine succinate sustained-release 100 mg/day
干预措施: desvenlafaxine succinate sustained-release 100 mg/day (Drug)
Placebo
干预措施: placebo (Drug)
desvenlafaxine succinate sustained-release 50 mg/day
干预措施: desvenlafaxine succinate sustained-release 50 mg/day (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 (final on-therapy)
HAM-D17 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
- Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score(Baseline to Week 8 (final on-therapy))
- Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate(Baseline to Week 8 (final on-therapy))
- Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate(Baseline to week 8 (final on-therapy))
- Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score(Baseline to Week 8 (final on-therapy))
- Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)(Baseline to Week 8 (final on-therapy))
- Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)(Baseline to Week 8 (final on-therapy))