Memantine Treatment for Improving Rehabilitation Outcomes and Preventing Depression in Older Adults
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Memantine for Enhancement of Rehabilitation Efficacy and Prevention of Major Depressive Disorder in Older Adults|
- 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 ]
- Measures of helplessness [ Time Frame: Measured at Week 12 and Month 12 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.
Placebo Comparator: 2
Placebo distribution is planned to mimic the active drug.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183729
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Eric J. Lenze, MD||University of Pittsburgh|