Memantine Treatment for Improving Rehabilitation Outcomes and Preventing Depression in Older Adults
Memantine for Enhancement of Rehabilitation Efficacy and Prevention of Major Depressive Disorder in Older Adults
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Admission to a skilled nursing facility for rehabilitation within 3 months of recent disabling medical event (e.g., hip fracture)
- Medically stable (e.g., no active seizures, delirium, unstable pulse/blood pressure)
Exclusion Criteria:
- Aphasia or cognitive impairments sufficiently severe to prevent valid assessment (e.g., a score of less than 22 on the Mini Mental State Examination)
- Current major depressive episode
- History of or current psychosis or mania
- Current substance or alcohol abuse or dependence (within 3 months of study entry)
- Current use of memantine
- Sensitivity or contraindication to memantine
- End-stage kidney, liver, heart, or lung disease
- Recent hemorrhagic stroke
- A FIM score of greater than 70 (on a 91 point scale)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Memantine (1)
Memantine for 12 weeks
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Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.
Other Names:
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Placebo Comparator: Placebo (2)
Placebo for 12 weeks
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Placebo distribution is planned to mimic the active drug.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive Symptoms
Time Frame: week 0, week 12
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Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)
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week 0, week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Major Depressive Disorder
Time Frame: week 12
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cumulative incidence over 12 weeks of follow-up
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week 12
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Functional Recovery
Time Frame: week 0, week 12
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Functional Independence Msure, 13-item motor subscale (scale ranges 13-91, higher scores = better function)
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week 0, week 12
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric J. Lenze, MD, Washington University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Memantine
Other Study ID Numbers
- K23MH064196-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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