Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | August 2005 |
| End Date: | December 2011 |
Memantine Augmentation of Lamotrigine Incomplete Response in Bipolar Depression: A Randomized Placebo Controlled Clinical Trial
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.
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.
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.
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.
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.
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