The purpose of this study is to explore the effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder
12-week, open-label LDX trial for BED including fMRI assessments to test the following specific predictions: 1. At baseline, patients with BED will show greater ventral prefrontal, striatal, and amygdala brain activation to high-calorie food pictures (reward) than matched healthy comparison subjects. 2. After 12 weeks of LDX treatment, BED will exhibit reduced ventral prefrontal, striatal and amygdala brain activation to food cues compared to baseline. 3. BED patients who display cessation of binge eating and those who demonstrate clinical improvement after 12 weeks of LDX treatment will show greater reductions in ventral prefrontal, striatal, and amygdala brain activation to food pictures than patients who do not stop binge eating and those who do not improve, respectively.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
40
20 healthy controls and 20 women subjects with BED agreeing to a 12-week, open-label trial of LDX and fMRI assessments immediately before and after the 12 weeks of LDX treatment will be recruited
Lindner Center of HOPE
Mason, Ohio, United States
RECRUITINGMeasurement of ventral prefrontal, striatal, and amygdala brain activation, assessed using food cues.
Investigators will statistically compare the brain response to food pictures of BED patients before and after receiving 12 weeks of LDX treatment.
Time frame: Change from baseline to 12 weeks of brain activation
Clinical Global Impression Improvement Scale (CGI-I)
score between 1-7 (1 = very much improved, ranging to 7 = very much worse)
Time frame: weeks 1, 2, 3, 4, 6, 8, 10, 12
Yale Brown Obsessive-Compulsive Scale modified for binge eating (YBOC-BE)
Will examine to see if severity of YBOC-BE scores correlate with fMRI abnormalities at baseline; and whether improvement in this scale with LDX treatment correlate with improvement in fMRI abnormalities at Endpoint.
Time frame: weeks 0,1, 2, 3, 4, 6, 8, 10, 12
Binge Eating Scale (BES)
Will examine to see if severity of BES scores correlate with fMRI abnormalities at baseline; and whether improvement in this scale with LDX treatment correlate with improvement in fMRI abnormalities at Endpoint.
Time frame: weeks 0,1, 2, 3, 4, 6, 8, 10, 12
Weight
measured in kilograms
Time frame: weeks 0,1, 2, 3, 4, 6, 8, 10, 12
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