Memantine and Cognitive Dysfunction in Bipolar Disorder — Memantine  

Bipolar Disorder Clinical Trial

Official title: This is a Placebo-controlled Study. It Will Compare the Effects of Memantine With Placebo on Cognitive Dysfunction

Status Completed

Clinical Trial Summary

Memantine is a glutamate NMDA receptor antagonist which has shown efficacy in cognitive dysfunction due to moderate to severe Alzheimer disease (Reisberg et al., 2003).

The investigators propose to treat 75 subjects with bipolar disorder with minimal mood symptoms and cognitive dysfunction with memantine or placebo. The 75 subjects will be enrolled at three sites. The same study will be performed at all three sites, with each site functioning independently of the other.

The investigators study will include objective neuropsychological testing of memory and executive functions before and after treatment, as well as ratings of mood symptoms and subjective patient ratings of memory function at every study visit.

The principal aim of this study is to measure the efficacy of memantine on improving memory function in minimally symptomatic subjects with bipolar disorder. The investigators hypothesize that in minimally symptomatic subjects with bipolar disorder memantine will be efficacious in improving cognitive functions, as measured by the difference in neuropsychological test scores at the beginning and at the end of the trial.

Secondary analyses will test the role of memantine in improving residual mood symptoms (depression and mania) in subjects with bipolar disorder.

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.

There will be an optional open label 12-week extension to the study. Subjects will be restarted on memantine similar to the regimen in the first phase of the study. Subjects will meet with the investigators every four weeks (weeks 16, 20, and 24) for assessment as mentioned above. Neuropsychological testing will be repeated at week 24. It is the investigator's belief that this added timeline will better demonstrate any improvements in cognitive function.

Clinical Trial Description

Study: MEMANTINE AND COGNITIVE DYSFUNCTION IN BIPOLAR DISORDER The study design involves double-blind, prospective, and longitudinal treatment with flexible doses of memantine or placebo for 12 weeks in minimally symptomatic subjects with bipolar disorder and memory dysfunction. We will use objective neuropsychological testing of memory functions before and after treatment, as well as subjective patient ratings of memory throughout the treatment.

The primary analysis will compare neuropsychological test scores before and after treatment among subjects treated with memantine or placebo.

A minimum of 25 subjects with bipolar disorder will be enrolled. We will enroll subjects with bipolar disorder, diagnosed with the use of the Structured Clinical Interview for DSM-IV-TR Mood Module (SCID Mood Module) (screen visit only). Subjects will have baseline scores on the 17-item Hamilton Depression Rating Scale and on the Young Mania Rating Scale of 10 or lower. Both of these instruments will be administered by trained raters.

Visit Timeline:

Screen: Week -2; Baseline Visit: Week 0; Visit 1Week 4; Visit 2Week 8;Visit 3Week 12 ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Cognition Disorders

• NCT number: NCT00645476
• Study type: Interventional
• Source: Cedars-Sinai Medical Center
• Status: Completed
• Phase: N/A
• Start date: February 2006
• Completion date: June 2010