View Clinical Trial (Medical Research Study)
1H-MR Spectroscopy of Bipolar Depression Before and After Lamotrigine Treatment
| City: |
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Rochester |
| State: |
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Minnesota |
| Zip Code: |
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55905 |
| Conditions: |
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Bipolar Depression |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Bipolar Type I or II diagnosis.
- Currently depressed.
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| NCT ID: |
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NCT01042496 |
| Primary Contact: |
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Principal Investigator
Mark Frye, MD
Mayo Clinic
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| Backup Contact: |
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N/A |
| Location Contact: |
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Rochester, Minnesota 55905
United States
Lee J Gunderson
Email: gunderson.lee@mayo.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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