NCT01121484已完成4 期
A Multicenter, Parallel-Group, Randomized, 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of 50 mg Of DVS SR In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 439
- 试验地点
- 39
- 主要终点
- Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8
研究概览
简要总结
A multicenter, 10-week study to evaluate the efficacy and safety of 50 mg of desvenlafaxine succinate sustained-release formulation (DVS SR) versus placebo in the treatment of peri- and postmenopausal women 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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Peri- and postmenopausal women aged 40 to 70 years who are fluent in both written and spoken English.
- •Postmenopausal status defined by 12 consecutive months of spontaneous amenorrhea; less than 12 consecutive months with at least 6 consecutive months of spontaneous amenorrhea and a pre-baseline follicle-stimulating hormone (FSH) level >40 mIU/mL; or 6 months postsurgical bilateral oophorectomy (with or without hysterectomy). Perimenopausal women defined by the presence of any of the following within 6 months before baseline:
- •an absolute change of 7 days or more in menstrual cycle length within 6 months before baseline;
- •a change in menstrual flow amount (2 or more flow categories, eg, from light or moderately light to moderately heavy or heavy);
- •a change in duration (absolute change of 2 or more days); or
- •periods of amenorrhea lasting at least 3 months.
- •A primary diagnosis of major depressive disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR), single or recurrent episode, without psychotic features using the modified Mini International Neuropsychiatric Interview (MINI).
- •A Montgomery and Asberg Depression Rating Scale (MADRS) total score >=25 at the screening and baseline (day -1) visits and no more than a 5-point improvement from screening to baseline.
排除标准
- •Treatment with DVS SR (Pristiq®) at any time in the past and/or venlafaxine, ie, Effexor® or Effexor XR®, 1 year prior to baseline.
- •Treatment-resistant; eg, in the past 3 years if any of the following treatments have failed: (a) 3 or more previous adequate trials of >=2 classes of antidepressant medication, (b) electroconvulsive therapy, or (c) 2 adequate trials of psychotherapy (eg, behavior therapy, behavior-marital therapy).
- •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.
- •Known presence of raised intraocular pressure or history of narrow-angle glaucoma.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Drug)
desvenlafaxine succinate sustained-release
Experimental
干预措施: desvenlafaxine succinate sustained-release (Drug)
结局指标
主要结局
Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8
时间窗: Baseline, Week 8
HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, \& weight loss). Total score ranges from 0 to 52; higher scores indicate more severe depression. Change from baseline: score at observation minus score at baseline.
次要结局
- Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)(Week 8)
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8(Baseline, Week 8)
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8(Baseline, Week 8)
- Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)(Baseline, Week 8)
- Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8(Baseline, Week 8)
研究者
研究点 (39)
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