Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression
|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|
- Change in 17-item Hamilton Depression Rating Scale From Baseline to 8 Weeks (Baseline - 8 Wks) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Scale for measurement of depression severity. Total of scale is used. Total range is from 0 - 50 with higher score signifying higher severity of depression. Outcome measure is change in score from baseline to 8 wks.
|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: Placebo
No active medication, only placebo
Active Comparator: Memantine
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|