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

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
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
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.

Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Depressive symptoms [ Time Frame: Measured at Week 12 and Month 12 ] [ Designated as safety issue: No ]
Incidence of major depressive disorder [ Time Frame: Measured at Week 12 and Month 12 ] [ Designated as safety issue: No ]
Functional recovery [ Time Frame: Measured at Week 12 and Month 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Measures of helplessness [ Time Frame: Measured at Week 12 and Month 12 ] [ Designated as safety issue: No ]
Condition  Depression
Intervention  Drug: Memantine
Drug: Placebo
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  40
Start Date  August 2005
Completion Date December 2008
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)
Gender Both
Ages 60 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Eric J. Lenze, MD         lenzeej@upmc.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00183729
Organization ID K23 MH64196-02
Secondary IDs †† DATR AK-TNGP2
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Eric J. Lenze, MD     University of Pittsburgh    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date December 2007
First Received Date  September 14, 2005
Last Updated Date December 10, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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