Medication Treatment for Depression in Nursing Home Residents

Depression Clinical Trial

Official title:

Drug Treatment of Depression in the Nursing Home Aged

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00076622
• Other study ID #: R37MH051247
• Secondary ID: R37MH051247DSIR
• Status: Completed
• Phase: N/A
• First received: January 28, 2004
• Last updated: January 2, 2018
• Start date: November 2003
• Est. completion date: July 2009

Study information

• Verified date: January 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Antidepressant medication
Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
• No antidepressant medication
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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Falls Experienced by Participants Over Twelve Months of Surveillance		Measured from Baseline through Month Twelve
Secondary	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