Memantine and Cognitive Dysfunction in Bipolar Disorder
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: Memantine |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 40 |
| Study Start Date: | November 2005 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: Memantine
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnostic and Statistical Manual-IV diagnostic criteria for any bipolar disorder (type I, type II, and NOS) (diagnosed with the use of the Structured Clinical Interview for DSM-IV-TR Mood Module (SCID Mood Module)
- Written informed consent
- Men or women aged 18-65
- A baseline Hamilton-D 17 score of < 10 at screen and baseline visits.
- A baseline Young Mania Rating Scale score of < 10 at screen and baseline visits.
- No acute episodes of depression or mania for the previous 12 weeks.
- Massachusetts General Hospital Cognitive and Physical Functioning Scale: Cut-off : >15 or Everyday Cognition Self-Report Form: Average of all items >1.5 or Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): <12 years education, RBANS total scale score of <85 =12 years education, RBANS total scale score of <93 >12 years education, RBANS total scale score of <100
- Able to read and understand English.
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded from the study:
- Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
- Pregnant women, nursing mothers, or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, intrauterine device (IUD), s/p tubal ligation, partner with vasectomy).
- Serious or unstable medical illness, including liver impairment, kidney impairment, cardiovascular, hepatic, respiratory, endocrine, neurologic or hematologic disease.
- History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc).
- History or current diagnosis of the following DSM-IV psychiatric illness: 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 the last 12 months.
- History of multiple adverse drug reactions.
- Patients with mood congruent or mood incongruent psychotic features within the last 12 months.
- Clinical or laboratory evidence of hypothyroidism.
- Patients who have had an episode of acute depression or mania during the 12 weeks prior to enrollment.
- Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding enrollment.
- Patients taking drugs which alkalinize the urine
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Andrew A. Nierenberg, MD, Director, Bipolar Clinic and Research Program, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00586066 History of Changes |
| Other Study ID Numbers: | 2005-p-001651 |
| Study First Received: | December 21, 2007 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Massachusetts General Hospital:
|
Bipolar disorder Cognitive dysfunction Memantine NMDA antagonist |
Additional relevant MeSH terms:
|
Bipolar Disorder Cognition Disorders Affective Disorders, Psychotic Mood Disorders Mental Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Memantine Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013