Citalopram for agitation in Alzheimer's disease: design and methods.

Citalopram for agitation in Alzheimer's disease: design and methods.
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DOI:
10.1016/j.jalz.2011.01.007
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发表时间:
2012
期刊:
Alzheimer's & dementia : the journal of the Alzheimer's Association
影响因子:
--
通讯作者:
CitAD Research Group
CitAD Research Group
中科院分区:
其他
文献类型:
--
作者:
Drye LT;Ismail Z;Porsteinsson AP;Rosenberg PB;Weintraub D;Marano C;Pelton G;Frangakis C;Rabins PV;Munro CA;Meinert CL;Devanand DP;Yesavage J;Mintzer JE;Schneider LS;Pollock BG;Lyketsos CG;CitAD Research Group

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激越是阿尔茨海默病 (AD) 最常见的神经精神症状之一,会给患者和护理人员带来严重的不良后果。针对躁动的有证据支持的治疗方案是有限的。西酞普兰治疗阿尔茨海默病躁动 (CitAD) 研究旨在评估西酞普兰改善这些症状的潜力。 CitAD 是一项随机、双盲、安慰剂对照的多中心临床试验,其中按 1:1 的比例分配两个平行治疗组,并按临床中心进行随机分层。该研究在美国和加拿大的大学设有八个招募临床中心、一个主席办公室和一个协调中心。正在招募 200 名疑似阿尔茨海默病患者,他们患有临床上明显的躁动,但没有重度抑郁症。患者被随机分配接受西酞普兰(目标剂量为 30 毫克/天)或匹配的安慰剂。两个治疗组中患者的护理人员都接受结构化的心理社会治疗。将使用神经行为评定量表和 AD 合作研究 - 临床总体变化印象(这是主要结果)来比较治疗组之间的躁动。还将测量功能表现、认知、护理人员的痛苦以及不良和严重不良事件的发生率。作者认为,CitAD 中的设计元素是重要的特征,应纳入评估精神药物治疗阿尔茨海默病临床显着躁动的安全性和有效性的试验中。
Agitation is one of the most common neuropsychiatric symptoms of Alzheimer’s disease (AD), and is associated with serious adverse consequences for patients and caregivers. Evidence-supported treatment options for agitation are limited. The citalopram for agitation in Alzheimer’s disease (CitAD) study was designed to evaluate the potential of citalopram to ameliorate these symptoms. CitAD is a randomized, double-masked, placebo-controlled multicenter clinical trial with two parallel treatment groups assigned in a 1:1 ratio and randomization stratified by clinical center. The study has eight recruiting clinical centers, a chair’s office and a coordinating center located in university settings in the United States and Canada. 200 people having probable Alzheimer’s disease with clinically significant agitation and without major depression are being recruited. Patients are randomized to receive citalopram (target dose of 30 mg/day) or matching placebo. Caregivers of patients in both treatment groups receive a structured psychosocial therapy. Agitation will be compared between treatment groups using the NeuroBehavioral Rating Scale and the AD Cooperative Study- Clinical Global Impression of Change which are the primary outcomes. Functional performance, cognition, caregiver distress and rates of adverse and serious adverse events will also be measured. The authors believe the design elements in CitAD are important features to be included in trials assessing the safety and efficacy of psychotropic medications for clinically significant agitation in Alzheimer’s disease.
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