We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Medication Treatment for Depression in Nursing Home Residents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00076622
Recruitment Status : Completed
First Posted : January 29, 2004
Last Update Posted : April 29, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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 Phase
Depression Drug: Antidepressant medication Drug: No antidepressant medication Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drug Treatment of Depression in the Nursing Home Aged
Study Start Date : November 2003
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale total Score [ Time Frame: Measured at Month 12 ]

Secondary Outcome Measures :
  1. Number of falls [ Time Frame: Measured at Month 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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
More Information

Publications:
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: Joel Streim, Professor of Psychiatry, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00076622     History of Changes
Other Study ID Numbers: R37MH051247 ( U.S. NIH Grant/Contract )
DSIR AT-GP
First Posted: January 29, 2004    Key Record Dates
Last Update Posted: April 29, 2013
Last Verified: April 2013

Keywords provided by Joel Streim, University of Pennsylvania:
Antidepressant drugs
Nursing Homes

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