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Memantine and Cognitive Dysfunction in Bipolar Disorder
This study is currently recruiting participants.
Verified by Massachusetts General Hospital, December 2007
Sponsors and Collaborators: Massachusetts General Hospital
Forest Laboratories
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00586066
  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 IV

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Memantine Memantine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Memantine and Cognitive Dysfunction in Bipolar Disorder

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • California Verbal Learning Test [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rapid Visual Information Processing Task [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: November 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator 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.

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 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
Criteria

Inclusion Criteria:

  • DSM-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 YMRS score of < 10 at screen and baseline visits.
  • No acute episodes of depression or mania for the previous 12 weeks.
  • MGH Cognitive and Physical Functioning Scale: Cut-off : >15 or Everyday Cognition Self-Report Form: Average of all items >1.5 or 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, 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 (e.g., carbonic anhydrase inhibitors, sodium
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586066

Contacts
Contact: Rebecca M. Ametrano, B.A. 617-726-0997 rametrano@partners.org
Contact: Claire A. Tilley, B.A. 617-726-7591 catilley@partners.org

Locations
United States, California
Cedars Sinai Department of Psychiatry Recruiting
Los Angeles, California, United States, 90048
Contact: Lana Levi, B.A.     310-423-0744     lana.levi@cshs.org    
Principal Investigator: Mark Rappaport, M.D.            
United States, Illinois
Asher Depression Center, Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Jordana Segal, Psy.D.     312-695-2203     j-segal@northwestern.edu    
Principal Investigator: William Gilmer, M.D.            
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rebecca M. Ametrano, B.A.     617-726-0997     rametrano@partners.org    
Contact: Claire A. Tilley, B.A.     617-726-7591     catilley@partners.org    
Principal Investigator: Andrew A. Nierenberg, M.D.            
Sub-Investigator: Dan V. Iosifescu, M.D.            
Sub-Investigator: Thilo Deckersbach, Ph.D.            
Sponsors and Collaborators
Massachusetts General Hospital
Forest Laboratories
Investigators
Principal Investigator: Andrew A. Nierenberg, M.D. Massachusetts General Hospital
  More Information

Responsible Party: Massachusetts General Hospital ( Andrew A. Nierenberg, M.D., Professor of Psychiatry, Harvard Medical School )
Study ID Numbers: 2005-p-001651
Study First Received: December 21, 2007
Last Updated: December 21, 2007
ClinicalTrials.gov Identifier: NCT00586066  
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Bipolar disorder
Cognitive dysfunction
Memantine
NMDA antagonist

Study placed in the following topic categories:
Excitatory Amino Acids
Affective Disorders, Psychotic
Dopamine
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Bipolar Disorder
Mood Disorders
Memantine
Psychotic Disorders
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 14, 2009