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

Phase 4

Completed

• Conditions: Depression
• Interventions: Other: Placebo; Drug: Memantine

• Registration Number: NCT00183729
• Lead Sponsor: Eric Lenze

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 Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-16
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2016-07-01
• Results First Submitted QC: 2016-10-20
• Results First Posted: 2016-12-15
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (2)	Placebo	Placebo for 12 weeks
Memantine (1)	Memantine	Memantine for 12 weeks

Primary Outcome Measures

Name	Time	Method
Depressive Symptoms	week 0, week 12	Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)

Secondary Outcome Measures

Name	Time	Method
Incidence of Major Depressive Disorder	week 12	cumulative incidence over 12 weeks of follow-up
Functional Recovery	week 0, week 12	Functional Independence Msure, 13-item motor subscale (scale ranges 13-91, higher scores = better function)

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States