Medication Treatment for Depression in Nursing Home Residents

An observational study of Depression, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Depression
What is being tested?: Antidepressant medication and No antidepressant medication
How many people: 94 participants
Where: 1 siteUnited States
Study dates: Nov 2003to Jul 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

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

Who may be able to join

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

Who cannot join

Bedridden
Severe cognitive impairment

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Drug Treatment of Depression in the Nursing Home Aged

Read the 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.

Conditions: Depression
Being tested: Antidepressant medication, No antidepressant medication
Keywords: Antidepressant drugs, Nursing Homes
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00076622
Study group	Role	What they receive
Randomized to drug continuation		Participants assigned to continue current antidepressant medication Receives: Drug: Antidepressant medication
Randomized to drug discontinuation		Participants assigned to discontinue current antidepressant medication (no antidepressant medication) Receives: Drug: No antidepressant medication
Participant preference to continue drug		Chose to continue antidepressant medication Receives: Drug: Antidepressant medication
Participant preference to discontinue drug		Chose to discontinue antidepressant medication (no antidepressant medication) Receives: Drug: No antidepressant medication

What is being measured

The primary outcome is the main question the study is designed to answer.

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: Measured at Month 12
Number of Falls Experienced by Participants Over Twelve Months of Surveillance
Measured: Measured from Baseline through Month Twelve

Secondary outcomes (1)

Cognitive Function (MMSE)
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).
Measured: Measured at Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2003Jul 2009

First posted29 Jan 2004 (estimated)
Study startNov 2003
Primary completionJul 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00076622
Sponsor's protocol ID: R37MH051247
Other IDs: R37MH051247, DSIR AT-GP
Status last verified: Jan 2018
First submitted: 28 Jan 2004
Last updated: 31 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug Treatment of Depression in the Nursing Home Aged
ClinicalTrials.gov ID: NCT00076622
Acronym / sponsor ID: R37MH051247
Conditions: Depression
Keywords: Antidepressant drugs, Nursing Homes
Study type: Observational
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Nov 2003
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 29 Jan 2004 (estimated)
Results: Posted 31 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
Randomized to drug continuation	–	Drug: Antidepressant medicationParticipants assigned to continue current antidepressant medication
Randomized to drug discontinuation	–	Drug: No antidepressant medicationParticipants assigned to discontinue current antidepressant medication (no antidepressant medication)
Participant preference to continue drug	–	Drug: Antidepressant medicationChose to continue antidepressant medication
Participant preference to discontinue drug	–	Drug: No antidepressant medicationChose to discontinue antidepressant medication (no antidepressant medication)

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
Study population: Nursing home patients who were receiving antidepressant medications on an open-label basis, prescribed by their attending physicians.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

Bedridden
Severe cognitive impairment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Antidepressant medicationParticipants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.	Drug	Participant preference to continue drug, Randomized to drug continuation
No antidepressant medicationParticipants assigned to discontinue current medication (no antidepressant medication) will be monitored over a period of one year for recurrence of depression and related symptoms.	Drug	Participant preference to discontinue drug, Randomized to drug discontinuation

Primary outcome

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).
Number of Falls Experienced by Participants Over Twelve Months of Surveillance
Time frame: Measured from Baseline through Month Twelve

1 secondary outcome

Cognitive Function (MMSE)
Time frame: Measured at Month 12

Results and safety

Results posted to the registry on 31 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Randomized to Drug Continuation	23	23
Randomized to Drug Discontinuation	13	13
Participant Preference to Continue Drug	40	40
Participant Preference to Discontinue Drug	18	18

Primary outcome: Geriatric Depression Scale (GDS) Score

Time frame: Measured at Month 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Randomized Arm-continue n = 23	Randomized Arm-discontinue n = 13	Non Randomized/Preference Arm-continue n = 40	Non-Randomized Preference-discontinue n = 18
Value	5.11 (0.86)	5.03 (1.15)	4.59 (0.49)	4.64 (0.75)

Primary outcome: Number of Falls Experienced by Participants Over Twelve Months of Surveillance

Time frame: Measured from Baseline through Month Twelve. Number. Unit: number of falls

Measure	Randomized Arm-continue n = 23	Randomized Arm-discontinue n = 13	Non Randomized/Preference Arm-continue n = 40	Non-Randomized Preference-discontinue n = 18
Value	12	9	26	10

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Randomized to Drug Continuation	8 of 23 (34.8%)	21 of 23 (91.3%)	1 of 23
Randomized to Discontinuation	4 of 13 (30.8%)	12 of 13 (92.3%)	1 of 13
Participation Based Upon Preference (Continue)	14 of 40 (35%)	33 of 40 (82.5%)	1 of 40
Participation Based Upon Preference (Discontinue)	5 of 18 (27.8%)	17 of 18 (94.4%)	1 of 18

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationStreim 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joel E. Streim, MD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Depression, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geriatric Depression Scale (GDS) Score (time frame: Measured at Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00076622, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.