Medication Treatment for Depression in Nursing Home Residents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joel Streim, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00076622
First received: January 28, 2004
Last updated: April 25, 2013
Last verified: April 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Drug Treatment of Depression in the Nursing Home Aged

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale total Score [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of falls [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: Yes ]

Enrollment: 94
Study Start Date: November 2003
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Experimental: 2
Participants assigned to discontinue current antidepressant medication
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076622

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Joel E. Streim, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Joel Streim, Professor of Psychiatry, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00076622     History of Changes
Other Study ID Numbers: R37 MH051247, R37MH051247, DSIR AT-GP
Study First Received: January 28, 2004
Last Updated: April 25, 2013
Health Authority: United States: Federal Government

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014