Memantine Treatment for Improving Rehabilitation Outcomes and Preventing Depression in Older Adults
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|ClinicalTrials.gov Identifier: NCT00183729|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : December 15, 2016
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Memantine Other: Placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Memantine for Enhancement of Rehabilitation Efficacy and Prevention of Major Depressive Disorder in Older Adults|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Experimental: Memantine (1)
Memantine for 12 weeks
Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.
Other Name: Namenda
Placebo Comparator: Placebo (2)
Placebo for 12 weeks
Placebo distribution is planned to mimic the active drug.
- Depressive Symptoms [ Time Frame: week 0, week 12 ]Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)
- Incidence of Major Depressive Disorder [ Time Frame: week 12 ]cumulative incidence over 12 weeks of follow-up
- Functional Recovery [ Time Frame: week 0, week 12 ]Functional Independence Msure, 13-item motor subscale (scale ranges 13-91, higher scores = better function)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183729
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Eric J. Lenze, MD||Washington University School of Medicine|