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| Sponsored by: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00076622 |
Purpose
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.
| Condition | Intervention | Phase |
|
Depression |
Drug: Antidepressant medication Drug: No antidepressant medication |
Phase IV |
| MedlinePlus related topics: | Depression |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Drug Treatment of Depression in the Nursing Home Aged |
| Estimated Enrollment: | 240 |
| Study Start Date: | November 2003 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Participants assigned to continue current antidepressant medication
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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.
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2: Experimental
Participants assigned to discontinue current antidepressant medication
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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.
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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.
Eligibility
| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Suzanne DiFilippo | 215-349-8228 | difilipp@mail.med.upenn.edu |
| Contact: Joel E. Streim, MD | 215-349-8226 | jstreim@mail.med.upenn.edu |
| United States, Pennsylvania | |||||
| University of Pennsylvania | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19104 | |||||
| Principal Investigator: Joel E. Streim, MD | |||||
| Principal Investigator: | Joel E. Streim, MD | University of Pennsylvania |
More Information
| Responsible Party: | National Institute of Mental Health ( Jovier Evans, PhD, Program Officer ) |
| Study ID Numbers: | R37 MH51247, DSIR AT-GP |
| First Received: | January 28, 2004 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00076622 |
| Health Authority: | United States: Federal Government |
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