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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183729
• Other study ID #: K23MH064196-02
• Secondary ID: K23MH064196-02
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: December 18, 2017
• Start date: August 2005
• Est. completion date: June 2009

Study information

• Verified date: December 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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:
• Placebo
Placebo distribution is planned to mimic the active drug.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Eric Lenze	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lenze EJ, Skidmore ER, Begley AE, Newcomer JW, Butters MA, Whyte EM. Memantine for late-life depression and apathy after a disabling medical event: a 12-week, double-blind placebo-controlled pilot study. Int J Geriatr Psychiatry. 2012 Sep;27(9):974-80. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive Symptoms	Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)	week 0, week 12
Secondary	Incidence of Major Depressive Disorder	cumulative incidence over 12 weeks of follow-up	week 12
Secondary	Functional Recovery	Functional Independence Msure, 13-item motor subscale (scale ranges 13-91, higher scores = better function)	week 0, week 12