Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression

Last updated: June 16, 2016
Sponsor: Indiana University School of Medicine
Overall Status: Completed

Phase

4

Condition

Depression

Mood Disorders

Depression (Treatment-resistant)

Treatment

N/A

Clinical Study ID

NCT00305578
0501-43
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:: 1) age 18 - 65; 2) satisfy DSM-IV-TR criteria for Bipolar Disorder andMajor Depressive Episode; 3) Lamotrigine Inadequate-Response: Defined as already treatedwith at least 100 mg of lamotrigine for at least 4 weeks but 17 item HDRS rating > 15; 4)give informed consent as approved by local IRB; 5) if on other antidepressants or moodstabilizers on stable dose for the past 4 weeks.

Exclusion

Exclusion Criteria:1) comorbid psychotic disorder such as schizophrenia or schizoaffectivedisorder; 2) significant suicidal or homicidal risk; 3) clinically significant medicalillness; 4) allergy or intolerance to lamotrigine or memantine; 5) pregnancy, planning tobe pregnant or not using adequate contraception; 6) satisfy criteria for substancedependence within 6 months prior to start of the study; and 7) on any medication withsignificant adverse interaction with either lamotrigine or memantine.

Study Design

Total Participants: 29
Study Start date:
August 01, 2005
Estimated Completion Date:
December 31, 2011

Study Description

Hypothesis/Objectives:

H1: Lamotrigine inadequate-response patients augmented with memantine for 8 weeks will have significantly greater improvement on the Hamilton Depression Rating Scale (HDRS) and Clinical Global Improvement (CGI) scale compared to patients augmented with placebo.

H2: Lamotrigine inadequate-response patients augmented with memantine for 8 weeks will have significantly greater improvement of scores on the Selective Reminding Test (SRT), the Digit Span Test, the Stroop Test, and Trail Making Test (TMT) than patients augmented with placebo.

Study Population:

We will study 40 bipolar disorder depressed (BDD) outpatients (20 in each arm) recruited from the outpatient Mood Disorders Clinic and by advertisement.

Connect with a study center

  • Indiana University Adult Psychiatric Clinic

    Indianapolis, Indiana 46202
    United States

    Site Not Available

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