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

Study Overview
=================
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.

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

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Memantine
* Other: Placebo


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Memantine (1)<br>Memantine for 12 weeks | Drug: Memantine<br>* Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.<br>* Other names: Namenda;|
| Placebo Comparator: Placebo (2)<br>Placebo for 12 weeks | Other: Placebo<br>* Placebo distribution is planned to mimic the active drug.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptoms | Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression) | week 0, week 12 | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major depressive disorder, Rehabilitating, Elderly, Apathy