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Medication Treatment for Depression in Nursing Home Residents

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ClinicalTrials.gov Identifier: NCT00076622
Recruitment Status : Completed
First Posted : January 29, 2004
Results First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment
Depression Drug: Antidepressant medication Drug: No antidepressant medication

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.


Study Type : Observational
Actual Enrollment : 94 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Treatment of Depression in the Nursing Home Aged
Study Start Date : November 2003
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Randomized to drug continuation
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.

Randomized to drug discontinuation
Participants assigned to discontinue current antidepressant medication (no antidepressant medication)
Drug: 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.

Participant preference to continue drug
Chose to continue 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.

Participant preference to discontinue drug
Chose to discontinue antidepressant medication (no antidepressant medication)
Drug: 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.




Primary Outcome Measures :
  1. Geriatric Depression Scale (GDS) Score [ Time Frame: Measured at Month 12 ]
    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).

  2. Number of Falls Experienced by Participants Over Twelve Months of Surveillance [ Time Frame: Measured from Baseline through Month Twelve ]

Secondary Outcome Measures :
  1. Cognitive Function (MMSE) [ Time Frame: Measured at Month 12 ]
    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).



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Nursing home patients who were receiving antidepressant medications on an open-label basis, prescribed by their attending physicians.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076622


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Joel E. Streim, MD University of Pennsylvania

Publications of Results:
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.

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00076622     History of Changes
Other Study ID Numbers: R37MH051247 ( U.S. NIH Grant/Contract )
R37MH051247 ( U.S. NIH Grant/Contract )
DSIR AT-GP
First Posted: January 29, 2004    Key Record Dates
Results First Posted: January 31, 2018
Last Update Posted: January 31, 2018
Last Verified: January 2018

Keywords provided by University of Pennsylvania:
Antidepressant drugs
Nursing Homes

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs