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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00183729
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : December 15, 2016
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Eric Lenze, University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depression Drug: Memantine Other: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Memantine for Enhancement of Rehabilitation Efficacy and Prevention of Major Depressive Disorder in Older Adults
Study Start Date : August 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Memantine (1)
Memantine for 12 weeks
 Drug: Memantine
Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.
Other Name: Namenda
Placebo Comparator: Placebo (2)
Placebo for 12 weeks
 Other: Placebo
Placebo distribution is planned to mimic the active drug.


Outcome Measures
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Primary Outcome Measures :
  1. Depressive Symptoms [ Time Frame: week 0, week 12 ]
    Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)


Secondary Outcome Measures :
  1. Incidence of Major Depressive Disorder [ Time Frame: week 12 ]
    cumulative incidence over 12 weeks of follow-up

  2. Functional Recovery [ Time Frame: week 0, week 12 ]
    Functional Independence Msure, 13-item motor subscale (scale ranges 13-91, higher scores = better function)


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183729


Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Eric Lenze
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Eric J. Lenze, MD Washington University School of Medicine
More Information
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Publications of Results:

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Responsible Party: Eric Lenze, Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00183729    
Other Study ID Numbers: K23MH064196-02 ( U.S. NIH Grant/Contract )
K23MH064196-02 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2005    Key Record Dates
Results First Posted: December 15, 2016
Last Update Posted: January 17, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Keywords provided by Eric Lenze, University of Pittsburgh:
Major depressive disorder
Rehabilitating
Elderly
Apathy
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Memantine
Antiparkinson Agents
 Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents