Medication Treatment for Depression in Nursing Home Residents

Completed

• Conditions: Depression
• Interventions: Drug: Antidepressant medication; Drug: No antidepressant medication

• Registration Number: NCT00076622
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2004-01-28
• Study First Submitted QC: 2004-01-28
• Study First Posted: 2004-01-29
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2017-03-28
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-02
• Last Update Submitted: 2018-01-02
• Results First Posted: 2018-01-31
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

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Exclusion Criteria

• Bedridden
• Severe cognitive impairment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Randomized to drug continuation	Antidepressant medication	Participants assigned to continue current antidepressant medication
Randomized to drug discontinuation	No antidepressant medication	Participants assigned to discontinue current antidepressant medication (no antidepressant medication)
Participant preference to continue drug	Antidepressant medication	Chose to continue antidepressant medication
Participant preference to discontinue drug	No antidepressant medication	Chose to discontinue antidepressant medication (no antidepressant medication)

Primary Outcome Measures

Name	Time	Method
Number of Falls Experienced by Participants Over Twelve Months of Surveillance	Measured from Baseline through Month Twelve
Geriatric Depression Scale (GDS) Score	Measured at Month 12	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).

Secondary Outcome Measures

Name	Time	Method
Cognitive Function (MMSE)	Measured at Month 12	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).

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States