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Memantine Treatment for Improving Rehabilitation Outcomes and Preventing Depression in Older Adults

Primary Purpose

Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Memantine
Placebo
Sponsored by
Eric Lenze
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Major depressive disorder, Rehabilitating, Elderly, Apathy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Memantine (1)

Placebo (2)

Arm Description

Memantine for 12 weeks

Placebo for 12 weeks

Outcomes

Primary Outcome Measures

Depressive Symptoms
Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)

Secondary Outcome Measures

Incidence of Major Depressive Disorder
cumulative incidence over 12 weeks of follow-up
Functional Recovery
Functional Independence Msure, 13-item motor subscale (scale ranges 13-91, higher scores = better function)

Full Information

First Posted
September 14, 2005
Last Updated
December 18, 2017
Sponsor
Eric Lenze
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00183729
Brief Title
Memantine Treatment for Improving Rehabilitation Outcomes and Preventing Depression in Older Adults
Official Title
Memantine for Enhancement of Rehabilitation Efficacy and Prevention of Major Depressive Disorder in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eric Lenze
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Major depressive disorder, Rehabilitating, Elderly, Apathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memantine (1)
Arm Type
Experimental
Arm Description
Memantine for 12 weeks
Arm Title
Placebo (2)
Arm Type
Placebo Comparator
Arm Description
Placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
Namenda
Intervention Description
Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo distribution is planned to mimic the active drug.
Primary Outcome Measure Information:
Title
Depressive Symptoms
Description
Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)
Time Frame
week 0, week 12
Secondary Outcome Measure Information:
Title
Incidence of Major Depressive Disorder
Description
cumulative incidence over 12 weeks of follow-up
Time Frame
week 12
Title
Functional Recovery
Description
Functional Independence Msure, 13-item motor subscale (scale ranges 13-91, higher scores = better function)
Time Frame
week 0, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric J. Lenze, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
22173933
Citation
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.
Results Reference
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Memantine Treatment for Improving Rehabilitation Outcomes and Preventing Depression in Older Adults

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