Medication Treatment for Depression in Nursing Home Residents

Study Overview
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Brief Summary
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This study will examine therapeutic and adverse effects of continuing versus discontinuing antidepressant medication in nursing home residents who have had no more than a single episode of depression and who no longer have depressive symptoms.

Detailed Description
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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.

Official Title
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Drug Treatment of Depression in the Nursing Home Aged

Conditions
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Depression

Intervention / Treatment
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* Drug: Antidepressant medication
* Drug: No antidepressant medication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Randomized to drug continuation<br>Participants assigned to continue current antidepressant medication | Drug: Antidepressant medication<br>* Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.<br>|
| Randomized to drug discontinuation<br>Participants assigned to discontinue current antidepressant medication (no antidepressant medication) | Drug: No antidepressant medication<br>* 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.<br>|
| Participant preference to continue drug<br>Chose to continue antidepressant medication | Drug: Antidepressant medication<br>* Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.<br>|
| Participant preference to discontinue drug<br>Chose to discontinue antidepressant medication (no antidepressant medication) | Drug: No antidepressant medication<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geriatric Depression Scale (GDS) Score | 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). | Measured at Month 12 | 
| Number of Falls Experienced by Participants Over Twelve Months of Surveillance |  | Measured from Baseline through Month Twelve | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Function (MMSE) | 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). | Measured at Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antidepressant drugs, Nursing Homes