CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 29 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/NCT00305578
NCT00305578Phase 4Completed

Memantine Augmentation of Lamotrigine Incomplete Response in Bipolar Depression: A Randomized Placebo Controlled Clinical Trial

Indiana University·interventional·Posted Mar 22, 2006·Updated Jul 18, 2016

In Brief

A Phase 4 clinical trial evaluating Memantine and Placebo for Bipolar Depression. Completed, enrolled 29 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate whether addition of memantine to bipolar depression patients who have had an incomplete response to lamotrigine (Lamictal) which is frequently used to treat bipolar depression in the clinical setting. At present, memantine is approved for use in the treatment of Alzheimer's disease or dementia, but not for use for the treatment of bipolar depression. Subjects will be asked to participate because they are suffering from bipolar depression associated and have had an inadequate response to lamotrigine. Subjects will have to be on at least 100 mg per day, for at least 4 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 22, 2006
Enrollment StartAug 1, 2005
Primary CompletionDec 1, 2010
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.3 years ago

Interventions

Memantinedrug

Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study.

Placebodrug

No active medication, only placebo