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| Descriptive Information Fields | |||||||||
| Brief Title † | Medication Treatment for Depression in Nursing Home Residents | ||||||||
| Official Title † | Drug Treatment of Depression in the Nursing Home Aged | ||||||||
| 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. |
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| 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Montgomery Asberg Depression Rating Scale total Score [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Number of falls [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: Yes ] | ||||||||
| Condition † | Depression | ||||||||
| Intervention † | Drug: Antidepressant medication Drug: No antidepressant medication |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 240 | ||||||||
| Start Date † | November 2003 | ||||||||
| Completion Date | December 2008 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 65 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00076622 | ||||||||
| Organization ID | R37 MH51247 | ||||||||
| Secondary IDs †† | DSIR AT-GP | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2008 | ||||||||
| First Received Date † | January 28, 2004 | ||||||||
| Last Updated Date | March 3, 2008 | ||||||||
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