Medication Treatment for Depression in Nursing Home Residents
Drug Treatment of Depression in the Nursing Home Aged
연구 개요
상세 설명
There are approximately 1.6 million nursing home residents in the United States. More than one third of these residents are taking antidepressant medications (ADs). Although ADs are effective, evidence suggests that they can lead to significant adverse events, including an increased risk of falls and bone fractures. Many depressed nursing home residents suffer from an initial episode of late-life depression and do not meet guideline-based recommendations for maintenance treatment. This study will examine the benefits and risks of long-term AD treatment in depressed nursing home residents whose single episode of depression has been in continuous remission for at least six months.
Participants will be randomly assigned to either continue or discontinue AD treatment. Participants will be monitored over a period of one year for recurrence of depression and related symptoms, as well as for the occurrence of falls, fractures, and other adverse events. Medical chart review, self-reported mood symptoms, and depression scales will be used to assess participants.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Current use of antidepressant medication
- Have been in remission from first episode of depression for 6 months or longer
- Currently residing in a long term care or assisted living facility
Exclusion Criteria:
- Bedridden
- Severe cognitive impairment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Randomized to drug continuation
Participants assigned to continue current antidepressant medication
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Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
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Randomized to drug discontinuation
Participants assigned to discontinue current antidepressant medication (no antidepressant medication)
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Participants assigned to discontinue current medication (no antidepressant medication) will be monitored over a period of one year for recurrence of depression and related symptoms.
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Participant preference to continue drug
Chose to continue antidepressant medication
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Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
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Participant preference to discontinue drug
Chose to discontinue antidepressant medication (no antidepressant medication)
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Participants assigned to discontinue current medication (no antidepressant medication) will be monitored over a period of one year for recurrence of depression and related symptoms.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Geriatric Depression Scale (GDS) Score
기간: Measured at Month 12
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The GDS scale measures presence and severity of depressive symptoms in older adults.
Scores range from zero (no depression symptoms) to thirty (severe depression symptoms).
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Measured at Month 12
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Number of Falls Experienced by Participants Over Twelve Months of Surveillance
기간: Measured from Baseline through Month Twelve
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Measured from Baseline through Month Twelve
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cognitive Function (MMSE)
기간: Measured at Month 12
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The Mini Mental State Examination (MMSE) measures cognitive function in multiple domains, including memory, orientation, language, and executive function.
Scores range from zero (severe cognitive impairment) to thirty (intact cognitive function).
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Measured at Month 12
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공동 작업자 및 조사자
수사관
- 수석 연구원: Joel E. Streim, MD, University of Pennsylvania
간행물 및 유용한 링크
일반 간행물
- Streim JE, DiFilippo S, TenHave T, Mavandadi S, Weintraub D, Oslin D. Antidepressant discontinuation associated with cognitive decline in older adult residents of long-term care facilities. Am J Geriatr Psychiatry 20(3) (supplement 1): S147-148, 2012.
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 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. .