Bipolar Depression Before and After Lamotrigine Treatment With Lamictal® (1HMRS-BP)
This study will compare glutamate and other neurometabolites measured by proton magnetic resonance spectroscopy (1H-MRS) in bipolar I and II patients currently depressed with age-matched healthy controls. The study will also compare 1H-MRS of bipolar I and II patients before and after taking a 12-week course of lamotrigine. This study requires 8 visits over a 12 week period. These visits need to occurs at Mayo Clinic in Rochester, MN.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||1H-MR Spectroscopy of Bipolar Depression Before and After Lamotrigine Treatment|
- Montgomery-Åsberg Depression Rating Scale (MADRS) score [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- To evaluate, by 1H-MR spectroscopy at 3T, regional specificity [anterior cingulate (AC) vs. dorsolateral prefrontal cortex (DLPFC)] of cerebral metabolites (Glutamate, glutamine, NAA) in bipolar depression before and after Lamotrigine treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2009|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: Lamotrigine||
Drug: Lamotrigine 12 week open trial
25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks
Other Name: Lamictal®
Depression is the predominant prevailing pole in bipolar disorder and it is associated with substantial morbidity and mortality. However, in comparison to acute mania, bipolar depression is understudied both from the standpoint of its pathophysiology as well as clinical trials and FDA-approved treatments. With little guidance, clinicians and patients are limited as to what evidence-based treatment is available for bipolar depression. Proton magnetic resonance spectroscopy (1H-MRS) is a valuable, non-invasive method to study in-vivo brain biochemistry. Of the novel imaging paradigms, MRS is uniquely positioned to investigate biochemical mechanism of drug action that is objectively measurable and clinically relevant. As there is increasing interest in glutamatergic dysregulation in mood disorders, this project will utilize 1H-MRS at 3T to study glutamate and glutamine levels in brain regions implicated in bipolar disorder [anterior cingulate (Brodmann's areas 24a/b and 32) and dorsolateral prefrontal cortex (Brodmann's 9/46)]. The goal of this project is to evaluate whether anterior cingulate and prefrontal cortex glutamine, quantified as a CSF-corrected absolute concentration percent change from baseline, is associated with clinical remission (MADRS=12) to the anti-glutamatergic mood stabilizer lamotrigine.
This is a 5-year single-site study (RO1 MH079261) of bipolar depression utilizing 1H-MR spectroscopy at 3T before and after treatment with lamotrigine.. At baseline bipolar depressed subjects and age-matched controls will undergo a 1H-MRS on a GE 3T Signa MRI scanner at Mayo Clinic Rochester. The bipolar depressed subjects will then be placed on 12-week, open evaluation of lamotrigine monotherapy. After 12 weeks, the bipolar subjects will undergo a second 1H-MRS scan.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042496
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Lee J Gunderson firstname.lastname@example.org|
|Principal Investigator: Mark A Frye, M.D.|
|Principal Investigator:||Mark Frye, MD||Mayo Clinic|