Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression

Condition(s) targeted: Bipolar Depression

Intervention: Memantine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Indiana University School of Medicine

Official(s) and/or principal investigator(s):
Amit Anand, MD, Principal Investigator, Affiliation: Indiana University School of Medicine

Overall contact:
Abi French, MS, Phone: 317-274-0318, Email: abdfrenc@iupui.edu

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Improvement of scores on Hamilton Depression Rating Scale and Clinical Global Improvement Scale given once a week for eight weeks

Improvement of scores on Selective Reminding Test, Digit Span Test, Stroop Test, and Trail Making Test

Detailed 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:: 1) age 18 - 65; 2) satisfy DSM-IV-TR criteria for Bipolar Disorder and

Major Depressive Episode; 3) Lamotrigine Inadequate-Response: Defined as already treated with 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 mood stabilizers on stable dose for the past 4 weeks.

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

Abi French, MS, Phone: 317-274-0318, Email: abdfrenc@iupui.edu

Indiana University Adult Psychiatric Clinic, Indianapolis, Indiana 46202, United States; Recruiting
Abi French, MS, Phone: 317-274-0318, Email: abdfrenc@iupui.edu

Starting date: August 2005
Ending date: December 2010
Last updated: July 31, 2008