Memantine Treatment for Improving Rehabilitation Outcomes and Preventing Depression in Older Adults - Full Text View

Purpose

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	Intervention	Phase
Depression	Drug: Memantine Drug: Placebo	Phase IV

MedlinePlus related topics:

Depression

ChemIDplus related topics:

Memantine Memantine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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 Measures:

Measures of helplessness [ Time Frame: Measured at Week 12 and Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	August 2005
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Experimental Memantine	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.
2: Placebo Comparator Placebo	Drug: Placebo Placebo distribution is planned to mimic the active drug.

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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183729

Contacts


Contact: Eric J. Lenze, MD		lenzeej@upmc.edu

Locations


United States, Pennsylvania
	University of Pittsburgh Medical Center	Recruiting
	Pittsburgh, Pennsylvania, United States, 15213
	Contact: Eric J. Lenze, MD lenzeej@upmc.edu

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Eric J. Lenze, MD	University of Pittsburgh

More Information

Responsible Party:	University of Pittsburgh ( Ellen Whyte, MD )
Study ID Numbers:	K23 MH64196-02, DATR AK-TNGP2
First Received:	September 14, 2005
Last Updated:	December 10, 2007
ClinicalTrials.gov Identifier:	NCT00183729
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Major depressive disorder

Rehabilitating

Elderly

Apathy

Study placed in the following topic categories:

Excitatory Amino Acids

Dopamine

Depression

Mood Disorders

Memantine

Depressive Disorder, Major

Depressive Disorder

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Physiological Effects of Drugs

Antiparkinson Agents

Excitatory Amino Acid Agents

Pharmacologic Actions

Behavioral Symptoms

Mental Disorders

Therapeutic Uses

Dopamine Agents

Central Nervous System Agents

Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on May 15, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00183729