CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 72 enrolled
Drug / intervention
Memantine +1 moredrug
Likely dose
Memantine 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00586066
NCT00586066Phase 4Completed

Memantine and Cognitive Dysfunction in Bipolar Disorder

Massachusetts General Hospital·interventional·Posted Jan 4, 2008·Updated Oct 6, 2017

In Brief

A Phase 4 clinical trial evaluating Memantine and Placebo for Bipolar Disorder. Completed, enrolled 72 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsForest Laboratories

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 4, 2008
Enrollment StartNov 1, 2005
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 18.5 years ago

Interventions

Memantinedrug

Week 0: 5 mg memantine or placebo once a day (q.d.) Week 1: 5 mg memantine or placebo twice a day (b.i.d.) Week 2-3: 5 mg memantine or placebo once in the morning (q.a.m.)/10 mg once in the evening (q.p.m.) Week 4-12: 10mg Memantine or placebo b.i.d.

Placebodrug

Inactive comparator. Placebo-matching memantine tablet.