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Completed

NCT Number: NCT00183729

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Namenda

Placebo

Other

Placebo distribution is planned to mimic the active drug.

Primary outcomes

  1. Depressive Symptoms

    Time frame: week 0, week 12

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

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Eric Lenze

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Memantine for Enhancement of Rehabilitation Efficacy and Prevention of Major Depressive Disorder in Older Adults

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 16, 2005
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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