NCT02659488

Lisdexamfetamine in Binge Eating Disorder (BED): fMRI Effects

Effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Lindner Center of HOPE · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to explore the effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder

Detailed description

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.

Conditions

• Binge Eating Disorder

Interventions

Type	Name	Description
DRUG	Lisdexamfetamine	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

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-09-01
• Completion: 2017-12-01
• First posted: 2016-01-20
• Last updated: 2016-01-20

Locations

1 site across 1 country: United States