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| Descriptive Information Fields | |||||
| Brief Title † | Memantine Treatment for Improving Rehabilitation Outcomes and Preventing Depression in Older Adults | ||||
| Official Title † | Memantine for Enhancement of Rehabilitation Efficacy and Prevention of Major Depressive Disorder in Older Adults | ||||
| 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. |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | 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 ] |
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| Secondary Outcome Measure † | Measures of helplessness [ Time Frame: Measured at Week 12 and Month 12 ] [ Designated as safety issue: No ] | ||||
| Condition † | Depression | ||||
| Intervention † | Drug: Memantine Drug: Placebo |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 40 | ||||
| Start Date † | August 2005 | ||||
| Completion Date | December 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 60 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00183729 | ||||
| Organization ID | K23 MH64196-02 | ||||
| Secondary IDs †† | DATR AK-TNGP2 | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | December 2007 | ||||
| First Received Date † | September 14, 2005 | ||||
| Last Updated Date | December 10, 2007 | ||||