Trial Information

Summary: Memantine and Cognitive Dysfunction in Bipolar Disorder

Many patients with bipolar disorder experience significant cognitive dysfunction even with adequate treatment of the disorder. Memantine is an FDA-approved drug for use in treatment cognitive dysfunction associated with Alzheimer's disease. This placebo-controlled, double-blind study seeks to measure the effectiveness of memantine in improving memory function in people with bipolar disorder who have minimal mood symptoms. The effectiveness of the treatment will be evaluated using various questionnaires and neuropsychological tests administered throughout the study.

The study will consist of 5 visits over the course of 12 weeks. Subjects will be randomly assigned to either a study group receiving memantine or a placebo study group receiving an inactive substance. Neither the subjects nor the investigator will know which group the subjects are assigned into. A study doctor will monitor all subjects throughout the study.

Subjects will not incur a charge for study medication, and in addition subjects will receive $10 for each visit and $50 for each completed neuropsychological testing series for a total of $140 if the subject should complete the entire study.

At the end of the study, all subjects will be given the option to continue the research study by repeating the 12-week study. However, in this extension, instead of the possibility of a placebo group, all subjects will receive the study medication, memantine.

Patient Inclusion Criteria:

• Subject diagnosed with bipolar disorder as assessed by study staff
• Men and women 18-65 years of age
• Subject has not had acute episode of depression or mania for previous 12 weeks
• Subject must be stable on bipolar medication for at least 12 weeks prior to study enrollment
• Subject able to read and understand English

Patient Exclusion Criteria:

• Subjects with suicidal ideation
• Pregnant women or nursing mothers
• Subjects with serious or unstable medical illness, including liver impairment, kidney impairment, cardiovascular, hepatic, respiratory, endocrine, neurologic, or hematologic disease
• Subjects with a history of seizure disorder, brain injury, any history of known neurological disease
• Subjects with history or current diagnosis of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, major depressive disorder, patients with substance dependence disorders including alcohol active within last 12 months
• Subjects with a history of multiple adverse drug reactions
• Subjects with mood congruent or mood incongruent psychotic features within the last 12 months
• Clinical or laboratory evidence of hypothroidism
• Subjects who have had an episode of acute depression or mania during the 12 weeks prior to enrollment
• Subjects who have had electroconvulsive therapy within the 6 months preceding enrollment

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.