An observational study in Depression, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2018-01-31.
Sponsored by University of Pennsylvania · Observational
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 94 is below the median of 160 across 1,084 observational studies indexed under Depression.
Browse Depression studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Nursing home patients who were receiving antidepressant medications on an open-label basis, prescribed by their attending physicians.
Exclusion Criteria:
Participants assigned to continue current antidepressant medication
Drug: Antidepressant medication
Participants assigned to discontinue current antidepressant medication (no antidepressant medication)
Drug: No antidepressant medication
Chose to continue antidepressant medication
Drug: Antidepressant medication
Chose to discontinue antidepressant medication (no antidepressant medication)
Drug: No antidepressant medication
Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
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.
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).
Time frame: Measured at Month 12
Number of Falls Experienced by Participants Over Twelve Months of Surveillance
Time frame: Measured from Baseline through Month Twelve
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).
Time frame: Measured at Month 12
| Milestone | Randomized to Drug Continuation | Randomized to Drug Discontinuation | Participant Preference to Continue Drug | Participant Preference to Discontinue Drug |
|---|---|---|---|---|
| Started | 23 | 13 | 40 | 18 |
| Completed | 23 | 13 | 40 | 18 |
| Not completed | 0 | 0 | 0 | 0 |
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).
| units on a scale | Randomized Arm-continue | Randomized Arm-discontinue | Non Randomized/Preference Arm-continue | Non-Randomized Preference-discontinue |
|---|---|---|---|---|
| Geriatric Depression Scale (GDS) Score | 5.11 ± 0.86 | 5.03 ± 1.15 | 4.59 ± 0.49 | 4.64 ± 0.75 |
| number of falls | Randomized Arm-continue | Randomized Arm-discontinue | Non Randomized/Preference Arm-continue | Non-Randomized Preference-discontinue |
|---|---|---|---|---|
| Number of Falls Experienced by Participants Over Twelve Months of Surveillance | 12 | 9 | 26 | 10 |
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).
| units on a scale | Randomized to Drug Continuation | Randomized to Drug Discontinuation | Participant Preference to Continue Drug | Participant Preference to Discontinue Drug |
|---|---|---|---|---|
| Cognitive Function (MMSE) | 23.1 ± 4.4 | 24.9 ± 4.0 | 24.4 ± 3.7 | 24.3 ± 4.5 |
Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Randomized to Drug Continuation | 1/23 (4.3%) | 8/23 (34.8%) | 21/23 (91.3%) |
| Randomized to Discontinuation | 1/13 (7.7%) | 4/13 (30.8%) | 12/13 (92.3%) |
| Participation Based Upon Preference (Continue) | 1/40 (2.5%) | 14/40 (35%) | 33/40 (82.5%) |
| Participation Based Upon Preference (Discontinue) | 1/18 (5.6%) | 5/18 (27.8%) | 17/18 (94.4%) |
| Event | Randomized to Drug Continuation | Randomized to Discontinuation | Participation Based Upon Preference (Continue) | Participation Based Upon Preference (Discontinue) |
|---|---|---|---|---|
| syncopeGeneral disorders | 0/23 | 3/13 | 1/40 | 0/18 |
| unstable angina with aspiration pneumoniaGeneral disorders | 1/23 | 0/13 | 3/40 | 2/18 |
| breast cancerReproductive system and breast disorders | 0/23 | 1/13 | 0/40 | 0/18 |
| fallInjury, poisoning and procedural complications | 0/23 | 1/13 | 1/40 | 0/18 |
| bronchitisInfections and infestations | 0/23 | 1/13 | 1/40 | 0/18 |
| congestive heart failureCardiac disorders | 0/23 | 0/13 | 0/40 | 1/18 |
| toxic metabolic encephalopathyMetabolism and nutrition disorders | 0/23 | 0/13 | 0/40 | 1/18 |
| urinary tract infectionInfections and infestations | 0/23 | 0/13 | 0/40 | 1/18 |
| weight lossMetabolism and nutrition disorders | 0/23 | 0/13 | 0/40 | 1/18 |
| hip fractureInjury, poisoning and procedural complications | 0/23 | 0/13 | 2/40 | 0/18 |
| Event | Randomized to Drug Continuation | Randomized to Discontinuation | Participation Based Upon Preference (Continue) | Participation Based Upon Preference (Discontinue) |
|---|---|---|---|---|
| fallGeneral disorders | 11/23 | 7/13 | 22/40 | 11/18 |
| upper respiratory infectionInfections and infestations | 5/23 | 7/13 | 6/40 | 5/18 |
| urinary tract infectionInfections and infestations | 3/23 | 5/13 | 10/40 | 2/18 |
| depressionPsychiatric disorders | 0/23 | 4/13 | 2/40 | 0/18 |
| diarrheaGastrointestinal disorders | 4/23 | 1/13 | 0/40 | 0/18 |
| skin tearSkin and subcutaneous tissue disorders | 2/23 | 1/13 | 2/40 | 3/18 |
| vomiting /nauseaGastrointestinal disorders | 3/23 | 2/13 | 2/40 | 3/18 |
| dizzinessGeneral disorders | 0/23 | 0/13 | 1/40 | 3/18 |
| decubitus ulcerSkin and subcutaneous tissue disorders | 1/23 | 2/13 | 1/40 | 1/18 |
| pneumoniaInfections and infestations | 0/23 | 2/13 | 3/40 | 0/18 |
| Age, Categorical(Participants) | Randomized to Drug Continuation | Randomized to Drug Discontinuation | Participant Preference to Continue Drug | Participant Preference to Discontinue Drug | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 23 | 13 | 40 | 18 | 94 |
| Sex: Female, Male(Participants) | Randomized to Drug Continuation | Randomized to Drug Discontinuation | Participant Preference to Continue Drug | Participant Preference to Discontinue Drug | Total |
|---|---|---|---|---|---|
| Female | 18 | 10 | 30 | 16 | 74 |
| Male | 5 | 3 | 10 | 2 | 20 |
| Race (NIH/OMB)(Participants) | Randomized to Drug Continuation | Randomized to Drug Discontinuation | Participant Preference to Continue Drug | Participant Preference to Discontinue Drug | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 6 | 0 | 5 | 2 | 13 |
| White | 17 | 13 | 34 | 16 | 80 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Randomized to Drug Continuation | Randomized to Drug Discontinuation | Participant Preference to Continue Drug | Participant Preference to Discontinue Drug | Total |
|---|---|---|---|---|---|
| United States | 23 | 13 | 40 | 18 | 94 |
| Geriatric Depression Scale(units on a scale) | Randomized to Drug Continuation | Randomized to Drug Discontinuation | Participant Preference to Continue Drug | Participant Preference to Discontinue Drug | Total |
|---|---|---|---|---|---|
| Mean | 4.3 ± 3.1 | 4.6 ± 2.9 | 4.5 ± 2.4 | 2.6 ± 1.5 | 4.3 ± 2.7 |
| Cognitive function (MMSE)(units on a scale) | Randomized to Drug Continuation | Randomized to Drug Discontinuation | Participant Preference to Continue Drug | Participant Preference to Discontinue Drug | Total |
|---|---|---|---|---|---|
| Mean | 23.1 ± 4.4 | 24.9 ± 4.0 | 24.4 ± 3.7 | 24.3 ± 4.5 | 24.1 ± 4.1 |
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Pennsylvania