Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Memantine Augmentation of Lamotrigine Incomplete Response in Bipolar Depression: A Randomized Placebo Controlled Clinical Trial|
- Improvement of scores on Hamilton Depression Rating Scale and Clinical Global Improvement Scale given once a week for eight weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Improvement of scores on Selective Reminding Test, Digit Span Test, Stroop Test, and Trail Making Test [ Time Frame: given every other week for 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1
No active medication, only placebo
Active Comparator: 2
Daily dose 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.
Other Name: Memantine or Namenda
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.
We will study 40 bipolar disorder depressed (BDD) outpatients (20 in each arm) recruited from the outpatient Mood Disorders Clinic and by advertisement.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305578
|United States, Indiana|
|Indiana University Adult Psychiatric Clinic|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Amit Anand, MD||Indiana University School of Medicine|