Medication Treatment for Depression in Nursing Home Residents
|Depression||Drug: Antidepressant medication Drug: No antidepressant medication||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Drug Treatment of Depression in the Nursing Home Aged|
- Montgomery Asberg Depression Rating Scale total Score [ Time Frame: Measured at Month 12 ]
- Number of falls [ Time Frame: Measured at Month 12 ]
|Study Start Date:||November 2003|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Participants assigned to continue current antidepressant medication
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.
Participants assigned to discontinue current antidepressant medication
Drug: No antidepressant medication
Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076622
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Joel E. Streim, MD||University of Pennsylvania|