A Pilot Study of Double-blind Comparison of Vilazodone to Paroxetine in Geriatric Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HDRS)
研究概览
简要总结
The purpose of this study is to examine the effects of vilazodone for the treatment of depression in older adults.
详细描述
This is a 12-week double-blind comparison of a novel antidepressant, vilazodone, to the gold-standard drug, paroxetine, for the treatment of geriatric depression. We are interested in assessing the difference in response to vilazodone (VLZ) compared to paroxetine (PAR). We hope to detect difference in response in primary outcomes (depressed mood) and secondary outcomes cognition. We are seeking to examine this directly in 80 older adults (60 years of age or older) with major depression with anticipated 60 completers. This proposed trial will serve as a pilot study to estimate the efficacy and tolerability of the drug in older depressed adults, and use this project for dose-finding in this population.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 years of age or older
- •The presence of a major depressive disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
- •A 24-item Hamilton Depression Rating Scale (HAMD) score of 17 or higher at baseline
- •Mini-Mental State Exam (MMSE) score > 24.
排除标准
- •Subjects will be excluded if they had any current and/or lifetime history of other psychiatric disorders (except unipolar depression with or without comorbid generalized anxiety disorder), or recent unstable medical or neurological disorders; any disabilities preventing their participation in the study; diagnosis of mild cognitive impairment (MCI)/dementia; those with known allergic reactions to paroxetine or vilazodone.
研究组 & 干预措施
Vilazodone; Viibryd
After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
干预措施: Vilazodone; Viibryd (Drug)
Paroxetine; Paxil
After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
干预措施: Paroxetine; Paxil (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale (HDRS)
时间窗: Baseline and 12 weeks
The HAMD measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms.
次要结局
- UKU Side-effect Profile(Each visit for 12 weeks)
- Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test(Baseline and Final Visit)
- Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)(Baseline and Final Visit)
研究者
Helen Lavretsky, MD
Professor
University of California, Los Angeles