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

Pfizer39 个研究点分布在 1 个国家目标入组 439 人2010年6月

适应症Major Depressive Disorder

干预措施desvenlafaxine succinate sustained-release placebo

概览

阶段: 4 期
干预措施: desvenlafaxine succinate sustained-release
疾病 / 适应症: Major Depressive Disorder
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
状态: 已完成
最后更新: 14年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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

注册库

clinicaltrials.gov

开始日期

2010年6月

结束日期

2011年6月

最后更新

14年前

研究类型

Interventional

研究设计

Parallel

性别

Female

研究者

发起方

Pfizer

责任方

Sponsor

入排标准

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

desvenlafaxine succinate sustained-release

干预措施: desvenlafaxine succinate sustained-release

Placebo

干预措施: placebo

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)