Bipolar Depression Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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