Drug Therapy for Generalized Anxiety Disorder Among the Elderly
Pharmacotherapy of Late-Life Generalized Anxiety Disorder
研究概览
详细说明
GAD is a serious public health issue; particularly among the elderly, prevalence of the condition is high, and functional burden on those with the illness is significant. GAD is associated with irregular levels of neurotransmitters, chemicals that carry messages across nerve endings. Serotonin is a neurotransmitter that helps regulate mood and emotions; increased levels of serotonin have been shown to reduce anxiety. Standard treatment for GAD typically involves selective serotonin reuptake inhibitors (SSRIs), drugs that reduce serotonin re-entry into nerve cells. Escitalopram is an SSRI that is well tolerated and highly specific for the serotonin transporter (SERT). The primary aim of this study is to examine the efficacy of escitalopram in reducing anxiety symptoms among elderly GAD patients. Additional aims include examining the efficacy of escitalopram for improving function, quality of life, and neuropsychological functioning, and examining whether genetic variation in the SERT gene influences these participants' response to treatment.
Participants will be randomly assigned to receive either escitalopram or placebo for 12 weeks (there is also a 12 week open label extension in which all participants will receive escitalopram). Participants will have weekly/biweekly study visits; during these visits, participants will complete self-report questionnaires on functional ability and anxiety symptoms. Blood collection and cognitive testing through various tasks will also occur.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosis of at least moderately severe generalized anxiety disorder (GAD)
Exclusion Criteria:
- Serious suicide risk or psychiatric instability that would affect study participation
- Dementia
- Substance abuse, such as alcoholism, within 6 months prior to study entry
- Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or bipolar disorder
- Unstable medical conditions that would preclude the use of escitalopram
- Use of certain psychotropics that can not be safely tapered or discontinued for at least 2 weeks prior to and during the study
- Use of neuroleptics that are absorbed over a prolonged period of time within 6 weeks prior to study entry
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Escitalopram (1)
Escitalopram
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Participants will either take 10 to 20 mg of escitalopram or placebo.
Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram.
其他名称：
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安慰剂比较：Placebo (2)
Placebo
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Participants will either take 10 to 20 mg of escitalopram or placebo.
Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Response Using Clinical Global Impressions-Improvement Scale (CGI-I)
大体时间：Measured at Weeks 1-12
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Cumulative incident response of anxiety symptom improvement on CGI-I, with 1 (very much improved) to 2 (much improved) indicated as response.
Scores synthesized from anxiety rating scale scores, including Penn State Worry Questionnaire (PSWQ) and Hamilton Anxiety Scale (HamA).
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Measured at Weeks 1-12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Quality of Life
大体时间：Measured at Week 12
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Role -emotional impairment score from the Late-Life Function and Disability Instrument (min score=0, significant impairment; max score=100, no impairment).
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Measured at Week 12
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合作者和调查者
调查人员
- 首席研究员：Eric J. Lenze, MD、University of Pittsburgh Medical Center
出版物和有用的链接
一般刊物
- Altmann H, Stahl ST, Gebara MA, Lenze EJ, Mulsant BH, Blumberger DM, Reynolds CF 3rd, Karp JF. Coprescribed Benzodiazepines in Older Adults Receiving Antidepressants for Anxiety and Depressive Disorders: Association With Treatment Outcomes. J Clin Psychiatry. 2020 Sep 29;81(6):20m13283. doi: 10.4088/JCP.20m13283.
- Lenze EJ, Rollman BL, Shear MK, Dew MA, Pollock BG, Ciliberti C, Costantino M, Snyder S, Shi P, Spitznagel E, Andreescu C, Butters MA, Reynolds CF 3rd. Escitalopram for older adults with generalized anxiety disorder: a randomized controlled trial. JAMA. 2009 Jan 21;301(3):295-303. doi: 10.1001/jama.2008.977.
- Butters MA, Bhalla RK, Andreescu C, Wetherell JL, Mantella R, Begley AE, Lenze EJ. Changes in neuropsychological functioning following treatment for late-life generalised anxiety disorder. Br J Psychiatry. 2011 Sep;199(3):211-8. doi: 10.1192/bjp.bp.110.090217. Epub 2011 Jul 4.
- Lenze EJ, Goate AM, Nowotny P, Dixon D, Shi P, Bies RR, Lotrich FK, Rollman BL, Shear MK, Thompson PA, Andreescu C, Pollock BG. Relation of serotonin transporter genetic variation to efficacy of escitalopram for generalized anxiety disorder in older adults. J Clin Psychopharmacol. 2010 Dec;30(6):672-7. doi: 10.1097/jcp.0b013e3181fc2bef.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- R01MH070547 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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