Medication Treatment for Depression in Nursing Home Residents

NCT ID: NCT00076622

Last Updated: 2018-01-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-11-30

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Randomized to drug continuation

Participants assigned to continue current antidepressant medication

Antidepressant medication

Intervention Type DRUG

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)

No antidepressant medication

Intervention Type DRUG

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

Antidepressant medication

Intervention Type DRUG

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)

No antidepressant medication

Intervention Type DRUG

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.

Interventions

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Antidepressant medication

Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joel E. Streim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT

Other Identifiers

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R37MH051247

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR AT-GP

Identifier Type: -

Identifier Source: secondary_id

R37MH051247

Identifier Type: NIH

Identifier Source: org_study_id

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