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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH064196-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or cardiopulmonary condition.
Depression is a serious medical illness that is often difficult to diagnose and treat. It occurs in people of all ages, but is often overlooked in older adults. Depression frequently co-occurs with other serious illnesses, and may be mistaken by both patients and health care givers as a normal consequence of the illness. However, these misconceptions toward depression contribute to the underdiagnosis and undertreatment of depressive disorders in older people. In turn, depression may hinder a patient's recovery from an illness. This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or a cardiopulmonary condition.
This double-blind study will last for 12 months. Participants will be randomly assigned to receive either placebo or memantine, which is a drug that is often used to treat Alzheimer's disease. Both memantine and placebo will be administered to participants for 12 weeks. All participants will be followed for an additional 40 weeks. Outcome measurements will include participants' depressive symptoms, motivation, and learned helplessness. In addition, medication side effects, functional outcome, and incidence of major depressive disorder will be measured. All measurements will be taken at Week 12 and Month 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Memantine (1) | Experimental | Memantine for 12 weeks |
|
| Placebo (2) | Placebo Comparator | Placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug | Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms | Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression) | week 0, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major Depressive Disorder | cumulative incidence over 12 weeks of follow-up | week 12 |
| Functional Recovery | Functional Independence Msure, 13-item motor subscale (scale ranges 13-91, higher scores = better function) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric J. Lenze, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22173933 | Result | Lenze EJ, Skidmore ER, Begley AE, Newcomer JW, Butters MA, Whyte EM. Memantine for late-life depression and apathy after a disabling medical event: a 12-week, double-blind placebo-controlled pilot study. Int J Geriatr Psychiatry. 2012 Sep;27(9):974-80. doi: 10.1002/gps.2813. Epub 2011 Dec 16. |
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study has small sample size and is unlikely to be useful for data sharing efforts; however, interested researchers can contact the first author via email.
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No significant events. Please see Lenze et al, Int J of Geriatric Psychiatry 2012 article for details.
35 subjects were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Memantine (1) | Memantine for 12 weeks Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day. |
| FG001 | Placebo (2) | Placebo for 12 weeks Placebo: Placebo distribution is planned to mimic the active drug. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Memantine (1) | Memantine for 12 weeks Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day. |
| BG001 | Placebo (2) |
| 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 | Depressive Symptoms | Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression) | Posted | Mean | Standard Deviation | units on a scale | week 0, week 12 |
|
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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 | Memantine (1) | Memantine for 12 weeks Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Lenze | Washington University School of Medicine | 314-362-1671 | lenzee@wustl.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| D053609 | Lethargy |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Other | Placebo distribution is planned to mimic the active drug. |
|
| week 0, week 12 |
Placebo for 12 weeks
Placebo: Placebo distribution is planned to mimic the active drug.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
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| Secondary | Incidence of Major Depressive Disorder | cumulative incidence over 12 weeks of follow-up | Posted | Count of Participants | Participants | week 12 |
|
|
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| Secondary | Functional Recovery | Functional Independence Msure, 13-item motor subscale (scale ranges 13-91, higher scores = better function) | intent to treat analysis; data presented are the week 12 data from the mixed effect model | Posted | Least Squares Mean | Standard Error | units on a scale | week 0, week 12 |
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|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Placebo (2) | Placebo for 12 weeks Placebo: Placebo distribution is planned to mimic the active drug. | 0 | 18 | 0 | 18 |
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| D001523 |
| Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |