Depression
Conditions
Keywords
Antidepressant drugs, Nursing Homes
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.
Interventions
Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
DRUGNo antidepressant medication
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.
Sponsors
National Institute of Mental Health (NIMH)
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geriatric Depression Scale (GDS) Score | 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 | Measured from Baseline through Month Twelve | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function (MMSE) | Measured at Month 12 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Randomized to Drug Continuation Participants assigned to continue current antidepressant medication
Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms. | 23 |
| Randomized to Drug Discontinuation Participants assigned to discontinue current antidepressant medication
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. | 13 |
| Participant Preference to Continue Drug Chose to continue antidepressant medication
Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms. | 40 |
| Participant Preference to Discontinue Drug Chose to stop antidepressant medication
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. | 18 |
| Total | 94 |
Baseline characteristics
| Characteristic | Randomized to Drug Continuation | Randomized to Drug Discontinuation | Participant Preference to Continue Drug | Participant Preference to Discontinue Drug | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 13 Participants | 40 Participants | 18 Participants | 94 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Cognitive function (MMSE) | 23.1 units on a scale STANDARD_DEVIATION 4.4 | 24.9 units on a scale STANDARD_DEVIATION 4 | 24.4 units on a scale STANDARD_DEVIATION 3.7 | 24.3 units on a scale STANDARD_DEVIATION 4.5 | 24.1 units on a scale STANDARD_DEVIATION 4.1 |
| Geriatric Depression Scale | 4.3 units on a scale STANDARD_DEVIATION 3.1 | 4.6 units on a scale STANDARD_DEVIATION 2.9 | 4.5 units on a scale STANDARD_DEVIATION 2.4 | 2.6 units on a scale STANDARD_DEVIATION 1.5 | 4.3 units on a scale STANDARD_DEVIATION 2.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 0 Participants | 5 Participants | 2 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 13 Participants | 34 Participants | 16 Participants | 80 Participants |
| Region of Enrollment United States | 23 Participants | 13 Participants | 40 Participants | 18 Participants | 94 Participants |
| Sex: Female, Male Female | 18 Participants | 10 Participants | 30 Participants | 16 Participants | 74 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 10 Participants | 2 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 23 | 1 / 13 | 1 / 40 | 1 / 18 |
| other Total, other adverse events | 21 / 23 | 12 / 13 | 33 / 40 | 17 / 18 |
| serious Total, serious adverse events | 8 / 23 | 4 / 13 | 14 / 40 | 5 / 18 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Arm-continue | Geriatric Depression Scale (GDS) Score | 5.11 units on a scale | Standard Deviation 0.86 |
| Randomized Arm-discontinue | Geriatric Depression Scale (GDS) Score | 5.03 units on a scale | Standard Deviation 1.15 |
| Non Randomized/Preference Arm-continue | Geriatric Depression Scale (GDS) Score | 4.59 units on a scale | Standard Deviation 0.49 |
| Non-Randomized Preference-discontinue | Geriatric Depression Scale (GDS) Score | 4.64 units on a scale | Standard Deviation 0.75 |
Primary
Number of Falls Experienced by Participants Over Twelve Months of Surveillance
Time frame: Measured from Baseline through Month Twelve
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Arm-continue | Number of Falls Experienced by Participants Over Twelve Months of Surveillance | 12 number of falls |
| Randomized Arm-discontinue | Number of Falls Experienced by Participants Over Twelve Months of Surveillance | 9 number of falls |
| Non Randomized/Preference Arm-continue | Number of Falls Experienced by Participants Over Twelve Months of Surveillance | 26 number of falls |
| Non-Randomized Preference-discontinue | Number of Falls Experienced by Participants Over Twelve Months of Surveillance | 10 number of falls |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Arm-continue | Cognitive Function (MMSE) | 23.1 units on a scale | Standard Deviation 4.4 |
| Randomized Arm-discontinue | Cognitive Function (MMSE) | 24.9 units on a scale | Standard Deviation 4 |
| Non Randomized/Preference Arm-continue | Cognitive Function (MMSE) | 24.4 units on a scale | Standard Deviation 3.7 |
| Non-Randomized Preference-discontinue | Cognitive Function (MMSE) | 24.3 units on a scale | Standard Deviation 4.5 |