Drug Therapy for Generalized Anxiety Disorder Among the Elderly
Pharmacotherapy of Late-Life Generalized Anxiety Disorder
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
- University of Pittsburgh Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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위약 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Response Using Clinical Global Impressions-Improvement Scale (CGI-I)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Quality of Life
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Eric J. Lenze, MD, University of Pittsburgh Medical Center
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- R01MH070547 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
불안 장애에 대한 임상 시험
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Jordi Zaragoza아직 모집하지 않음
Escitalopram에 대한 임상 시험
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University of Texas Southwestern Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)완전한
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Central South UniversityNational Natural Science Foundation of China; Second Xiangya Hospital of Central South...모집하지 않고 적극적으로
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Shanghai Mental Health CenterJiangsu Nhwa Pharmaceutical Co., Ltd.완전한