Clinical trial NCT00076622: Medication Treatment for Depression in Nursing Home Residents
Official title: Drug Treatment of Depression in the Nursing Home Aged
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: Antidepressant drugs
Nursing Homes
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2004-01-29
Enrollment: 94
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nursing home patients who were receiving antidepressant medications on an open-label basis, prescribed by their attending physicians.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Geriatric Depression Scale (GDS) Score
timeFrame: Measured at Month 12
measure: Number of Falls Experienced by Participants Over Twelve Months of Surveillance
timeFrame: Measured from Baseline through Month Twelve
Secondary outcomes:
measure: Cognitive Function (MMSE)
timeFrame: Measured at Month 12
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Joel E. Streim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.