NCT00076622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2004

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

January 31, 2018

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

5.7 years

First QC Date

January 28, 2004

Results QC Date

March 28, 2017

Last Update Submit

January 2, 2018

Conditions

Depression

Keywords

Antidepressant drugsNursing Homes

Outcome Measures

Primary Outcomes (2)

  • Geriatric Depression Scale (GDS) Score

    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).

    Measured at Month 12

  • Number of Falls Experienced by Participants Over Twelve Months of Surveillance

    Measured from Baseline through Month Twelve

Secondary Outcomes (1)

  • Cognitive Function (MMSE)

    Measured at Month 12

Study Arms (4)

Randomized to drug continuation

Participants assigned to continue current antidepressant medication

Drug: Antidepressant medication

Randomized to drug discontinuation

Participants assigned to discontinue current antidepressant medication (no antidepressant medication)

Drug: No antidepressant medication

Participant preference to continue drug

Chose to continue antidepressant medication

Drug: Antidepressant medication

Participant preference to discontinue drug

Chose to discontinue antidepressant medication (no antidepressant medication)

Drug: No antidepressant medication

Interventions

Antidepressant medicationDRUG

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 continue drugRandomized to drug continuation
No antidepressant medicationDRUG

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 discontinue drugRandomized to drug discontinuation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Nursing home patients who were receiving antidepressant medications on an open-label basis, prescribed by their attending physicians.

You may qualify if:

  • 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

You may not qualify if:

  • Bedridden
  • Severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

Depression

Interventions

Antidepressive Agents

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Psychotropic DrugsCentral Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Limitations and Caveats

Based on an a priori sample size calculation of 160 subjects needed, it is likely that the final sample (N=94) was insufficient to detect a significant difference on the primary outcome measures in the intent-to-treat analyses.

Results Point of Contact

Title
Joel Streim
Organization
University of Pennsylvania
Joel.Streim@uphs.upenn.edu

Study Officials

  • Joel E. Streim, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2004

First Posted

January 29, 2004

Study Start

November 1, 2003

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

January 31, 2018

Results First Posted

January 31, 2018

Record last verified: 2018-01

Locations

US(1)