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Memantine and Cognitive Dysfunction in Bipolar Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Memantine and Cognitive Dysfunction in Bipolar Disorder

NCT00586066•Massachusetts General Hospital

Summary

The purpose of this study is to see whether memantine improves memory function in participants with bipolar disorder who have minimal symptoms. Secondary analyses will test the role of memantine in improving residual mood symptoms (depression and mania) in participants with bipolar disorder. We hypothesize that in participants 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.

Detailed Description

A large proportion of participants 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 participant'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 participants with bipolar disorder promises to provide important clinical information, which could lead to improvements in well-being and functional status for large populations of participants with bipolar disorder.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for any bipolar disorder \[type I, type II, and not otherwise specified (NOS)\] (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:
•Participants 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 \[multiple sclerosis, degenerative disease such as amyotrophic lateral sclerosis (ALS), Parkinson disease and any movement disorders, etc\].
•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.
+2 more criteria

Locations (3)

Cedars Sinai Department of Psychiatry

Los Angeles, California, United States

Asher Depression Center, Northwestern University

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

November 1, 2005

Primary Completion Date

December 1, 2009

Completion Date

December 1, 2009

Last Updated

October 6, 2017

Enrollment

ACTUAL participants

Conditions

Bipolar Disorder

Interventions

Memantine

DRUG

Placebo

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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ManiaBipolar Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Memantine and Cognitive Dysfunction in Bipolar Disorder

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

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A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

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