Medication Treatment for Depression in Nursing Home Residents - Tabular View

Tracking Information

First Received Date ^ICMJE

January 28, 2004

Last Updated Date

April 21, 2009

Start Date ^ICMJE

November 2003

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00076622 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Medication Treatment for Depression in Nursing Home Residents

Official Title ^ICMJE

Drug Treatment of Depression in the Nursing Home Aged

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.

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: Antidepressant medication
Drug: No antidepressant medication

Study Arms / Comparison Groups

Experimental: Participants assigned to continue current antidepressant medication
Experimental: Participants assigned to discontinue current antidepressant medication

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

240

Estimated Completion Date

April 2009

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00076622

Responsible Party

Jovier Evans, PhD, Program Officer, National Institute of Mental Health

Study ID Numbers ^ICMJE

R37 MH051247, DSIR AT-GP

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Joel E. Streim, MD

University of Pennsylvania

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP