Bipolar Depression Before and After Lamotrigine Treatment

Completed · Phase 3

Conditions studied: Bipolar Depression

In brief

This study compared 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. The goal of this study was to better understand the neurobiology of bipolar depression and how lamotrigine may therapeutically impact brain function and mood response. The hypothesis was that in comparison to non-remission participants, bipolar participants who achieve remission (defined as a Montgomery Asberg Depression Rating Scale (MADRS) score \<12 at week 12) associated with lamotrigine monotherapy will exhibit a greater decrease in glutamate (Glu) and an increase in N-acetyl aspartate (NAA), reported as a cerebrospinal fluid (CSF)-corrected absolute concentration percent change from baseline to endpoint in anterior cingulate (AC) and dorsolateral prefrontal cortex (DLPFC).

Key facts

Study ID
NCT01042496
Run by
Mayo Clinic
People needed
72
Starts
2009-12-01
Expected to finish
2014-10-01
Last updated by the study team
2016-02-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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