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| ID | Type | Description | Link |
|---|---|---|---|
| R37MH051247 | U.S. NIH Grant/Contract | View source | |
| DSIR AT-GP |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized to drug continuation | Participants assigned to continue current antidepressant medication |
| |
| Randomized to drug discontinuation | Participants assigned to discontinue current antidepressant medication (no antidepressant medication) |
| |
| Participant preference to continue drug | Chose to continue antidepressant medication |
| |
| Participant preference to discontinue drug | Chose to discontinue antidepressant medication (no antidepressant medication) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antidepressant medication | Drug | Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 at Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Nursing home patients who were receiving antidepressant medications on an open-label basis, prescribed by their attending physicians.
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| Name | Affiliation | Role |
|---|---|---|
| Joel E. Streim, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Randomized to Drug Discontinuation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Measured at Month 12 |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization | General disorders | Systematic Assessment | reason not ascertained |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joel Streim | University of Pennsylvania | Joel.Streim@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000928 | Antidepressive Agents |
| ID | Term |
|---|---|
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
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| No antidepressant medication | Drug | 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. |
|
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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Geriatric Depression Scale | The Geriatric Depression Scale (GDS) measures presence and severity of depressive symptoms in older adults. Scores range from zero (no depression symptoms) to thirty (severe depression symptoms). | Mean | Standard Deviation | units on a scale |
|
| 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). | Mean | Standard Deviation | units on a scale |
|
Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to continue and were assigned to those groups based on their non-random choice. |
| OG003 | Non-Randomized Preference-discontinue | Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to discontinue, and were assigned to those groups based on their non-random choice. |
|
|
| Primary | Number of Falls Experienced by Participants Over Twelve Months of Surveillance | Posted | Number | number of falls | Measured from Baseline through Month Twelve |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Measured at Month 12 |
|
|
|
| 1 |
| 23 |
| 8 |
| 23 |
| 21 |
| 23 |
| EG001 | Randomized to 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. | 1 | 13 | 4 | 13 | 12 | 13 |
| EG002 | Participation Based Upon Preference (Continue) | 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. | 1 | 40 | 14 | 40 | 33 | 40 |
| EG003 | Participation Based Upon Preference (Discontinue) | 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. | 1 | 18 | 5 | 18 | 17 | 18 |
| bradycardia | Cardiac disorders | Systematic Assessment |
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| dehydration | Metabolism and nutrition disorders | Systematic Assessment | requiring acute hospitalization |
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| polytrauma from motor vehicle accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| myocardial infarction | Cardiac disorders | Systematic Assessment |
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| allergic reaction | Immune system disorders | Systematic Assessment |
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| unstable angina with aspiration pneumonia | General disorders | Systematic Assessment |
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| small bowel obstruction | Renal and urinary disorders | Systematic Assessment | requiring acute hospitalization |
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| breast cancer | Reproductive system and breast disorders | Systematic Assessment | exacerbation |
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| fall | Injury, poisoning and procedural complications | Systematic Assessment | with injury requiring hospitalization |
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| syncope | General disorders | Systematic Assessment | requiring hospitalization |
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| bronchitis | Infections and infestations | Systematic Assessment | requiring acute hospitalization |
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| cellulitis | Infections and infestations | Systematic Assessment |
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| hip dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| humerus fracture | Injury, poisoning and procedural complications | Systematic Assessment | resulting from a fall |
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| hip fracture | Injury, poisoning and procedural complications | Systematic Assessment | resulting from a fall |
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| transient ischemic attack | Nervous system disorders | Systematic Assessment |
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| deep vein thrombosis | Vascular disorders | Systematic Assessment | requiring hospitalization |
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| hypoglycemia | Endocrine disorders | Systematic Assessment |
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| tarry stool | Gastrointestinal disorders | Systematic Assessment | associated with a fall |
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| congestive heart failure | Cardiac disorders | Systematic Assessment | requiring hospitalization |
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| toxic metabolic encephalopathy | Metabolism and nutrition disorders | Systematic Assessment | requiring hospitalization |
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| urinary tract infection | Infections and infestations | Systematic Assessment |
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| weight loss | Metabolism and nutrition disorders | Systematic Assessment |
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| fall | General disorders | Systematic Assessment |
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| upper respiratory infection | Infections and infestations | Systematic Assessment |
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| urinary tract infection | Infections and infestations | Systematic Assessment |
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| depression | Psychiatric disorders | Systematic Assessment |
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| skin tear | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| vomiting /nausea | Gastrointestinal disorders | Systematic Assessment |
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| abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| anemia | General disorders | Systematic Assessment |
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| abscess | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| cellulitis | Infections and infestations | Systematic Assessment |
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| clostridium difficile infection | Infections and infestations | Systematic Assessment |
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| chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| colonic polyps | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| congestive heart failure | Cardiac disorders | Systematic Assessment |
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| constipation | Gastrointestinal disorders | Systematic Assessment |
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| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| decubitus ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| dizziness | General disorders | Systematic Assessment |
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| duodenal ulcer | Gastrointestinal disorders | Systematic Assessment |
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| dental infection | Infections and infestations | Systematic Assessment |
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| dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| epistaxis | General disorders | Systematic Assessment |
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| flank pain | Renal and urinary disorders | Systematic Assessment |
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| gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment |
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| gout | Metabolism and nutrition disorders | Systematic Assessment |
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| headache | Nervous system disorders | Systematic Assessment |
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| hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
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| herpes simplex | Infections and infestations | Systematic Assessment |
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| herpes zoster | Infections and infestations | Systematic Assessment |
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| hepatitis C | Infections and infestations | Systematic Assessment |
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| leg edema | General disorders | Systematic Assessment |
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| neuropathic pain | Nervous system disorders | Systematic Assessment | worsened |
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| ophthalmic infection | Eye disorders | Systematic Assessment |
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| osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| orthostatic hypotension | Vascular disorders | Systematic Assessment |
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| mental status change | Psychiatric disorders | Systematic Assessment |
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| pneumonia | Infections and infestations | Systematic Assessment |
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| rotator cuff syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| transient ischemic attack | Vascular disorders | Systematic Assessment |
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| tooth fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| skin blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| vertebral compression fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| weight loss | Metabolism and nutrition disorders | Systematic Assessment |
|
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| D020164 | Chemical Actions and Uses |