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Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression

NCT00305578 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2016-07-18

Study results available
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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.

Conditions

Interventions

DRUG

Memantine

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.

DRUG

Placebo

No active medication, only placebo

Sponsors & Collaborators

  • Indiana University School of Medicine

    lead OTHER

Principal Investigators

  • Amit Anand, MD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2010-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00305578 on ClinicalTrials.gov