Medication Treatment for Depression in Nursing Home Residents
Drug Treatment of Depression in the Nursing Home Aged
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Geriatric Depression Scale (GDS) Score
時間枠：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
時間枠：Measured from Baseline through Month Twelve
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Measured from Baseline through Month Twelve
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cognitive Function (MMSE)
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Joel E. Streim, MD、University of Pennsylvania
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Antidepressant medicationの臨床試験
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University of North Carolina, Chapel HillMedical University of South Carolina; National Institute of Mental Health (NIMH); University of... と他の協力者完了HIV/エイズ | 服薬アドヒアランス | HIV | 性的行動 | 性感染症 (HIV や肝炎ではない)アメリカ
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Fondazione Poliambulanza Istituto Ospedalieroわからない
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Smiths Medical, ASD, Inc.完了