Memantine and Cognitive Dysfunction in Bipolar Disorder
The purpose of this study is to see whether Memantine improves memory function in subjects with bipolar disorder who have minimal symptoms. Secondary analyses will test the role of Memantine in improving residual mood symptoms (depression and mania) in subjects with bipolar disorder.
We hypothesize that in subjects with bipolar disorder who have minimal symptoms Memantine will be effective in improving cognitive functions, as measured by the difference in neuropsychological test scores at the beginning and at the end of the trial.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Memantine and Cognitive Dysfunction in Bipolar Disorder|
- California Verbal Learning Test [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Rapid Visual Information Processing Task [ Time Frame: 4 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
|Placebo Comparator: 1||
Week 0 - 5mg Memantine or placebo q.d. Week 1 - 5mg Memantine or placebo b.i.d. Week 2-3 - 5mg Memantine or placebo q.a.m./10mg q.p.m. Week 4-12 - 10mg Memantine or placebo b.i.d.
Other Name: Namenda
A large proportion of subjects with bipolar disorder experience significant cognitive dysfunction, even when euthymic, after adequate treatment. The cognitive deficits in asymptomatic patients with bipolar disorder are very important for the subject's psychosocial function. In this population, cognitive deficits have been associated with poor psychosocial functioning, such as inability to hold a job. Memantine is a glutamate N-methyl-D-aspartate (NMDA) receptor antagonist which has shown efficacy in cognitive dysfunction due to moderate to severe Alzheimer disease.
Demonstrating the role of Memantine in reducing cognitive dysfunction in minimally symptomatic subjects with bipolar disorder promises to provide important clinical information, which could lead to improvements in well-being and functional status for large populations of subjects with bipolar disorder.
|United States, California|
|Cedars Sinai Department of Psychiatry|
|Los Angeles, California, United States, 90048|
|United States, Illinois|
|Asher Depression Center, Northwestern University|
|Chicago, Illinois, United States, 60611|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Andrew A. Nierenberg, M.D.||Massachusetts General Hospital|