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OpenTrials
Completed

NCT Number: NCT00076622

Medication Treatment for Depression in Nursing Home Residents

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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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antidepressant Medication

Drug

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

No antidepressant medication

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Drug Treatment of Depression in the Nursing Home Aged

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Jan 29, 2004
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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