Lamotrigine Therapy in Geriatric Bipolar Depression
We propose to study the efficacy and tolerability of lamotrigine in the treatment of older adults with bipolar depression and to compare measures of brain energy metabolism between older subjects with bipolar depression and healthy age-matched controls in order to better understand treatment response in geriatric bipolar depression.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Lamotrigine Therapy in the Treatment of Geriatric Bipolar Depression: An Evaluation of Markers of Cerebral Energy Metabolism|
- We will measure changes in mood symptom severity, as assessed by the Montgomery Asberg Depression Rating Scale. [ Time Frame: 8 Week Trial ] [ Designated as safety issue: No ]
- We will measure changes in lactate, glutamate, and NAA concentrations in individuals with bipolar depression before and after treatment with Lamotrigine. [ Time Frame: 8 Week Trial ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Study Completion Date:||December 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Open Label Study
Lamotrigine with dosage range from 25 mg to 200 mg per day.
Other Name: Lamictal
We will use MRI techniques and neuropsychological testing to investigate potential markers of treatment response in elderly bipolar depressed patients receiving lamotrigine and age-matched, non-depressed controls.
We intend to test these hypotheses:
- At least 50% of older subjects with bipolar depression will respond treatment with lamotrigine as evidenced by a 50% reduction on the Montgomery Asberg Rating Scale (MADRS). In addition, treatment with lamotrigine will be safe and well tolerated as evidenced by a drop-out rate of less than 10% due to adverse effects.
- Compared with healthy age-matched, non-demented, non-depressed controls, subjects with geriatric bipolar depression will demonstrate abnormalities in cerebral energy metabolism as assessed by elevated levels of glutamate and lactate, and decreased levels of NAA, using 1H MRS at 4T.
- Successful treatment with lamotrigine in geriatric bipolar depression will result in decreases in lactate and glutamate, and elevations in NAA.
- Baseline measures of executive functioning and information processing speed (measured by performance on the Wisconsin Card Sorting Test (WCST), Trails A and B and Stroop tests) will be impaired in subjects with geriatric bipolar depression compared with healthy controls. These measures will improve with successful treatment with lamotrigine and correlate with improvements in markers of cerebral energy metabolism (lactate, glutamate, NAA).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720473
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Principal Investigator:||Brent P Forester, MD||Mclean Hospital|