Lisdexamfetamine in Binge Eating Disorder (BED): fMRI Effects
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|ClinicalTrials.gov Identifier: NCT02659488|
Recruitment Status : Unknown
Verified January 2016 by Lindner Center of HOPE.
Recruitment status was: Recruiting
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Binge Eating Disorder||Drug: Lisdexamfetamine||Phase 2|
12-week, open-label LDX trial for BED including fMRI assessments to test the following specific predictions:
- 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.
- After 12 weeks of LDX treatment, BED will exhibit reduced ventral prefrontal, striatal and amygdala brain activation to food cues compared to baseline.
- 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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||December 2017|
During the Treatment Phase, subjects will be evaluated after 1, 2, 3, 4, 6, 8, 10, and 12 weeks (see Figure 2). The morning after completing the first fMRI scan, LDX will be started at 30 mg q AM (Baseline). After 1 week, LDX will then be increased to 50 mg q AM (Visit 1); after another week, LDX will be increased to 70 mg q AM (Visit 2). A single downward dose titration to 50 mg is allowed during week 3 if 70 mg/d is not tolerated. LDX dose at week 4 (50 or 70 mg/d) will be maintained for the next 8 weeks. Patients who do not tolerate 50 or 70 mg/day will be terminated. For patients who complete the 12-week treatment phase, LDX will be stopped at week 12 visit.
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
Other Name: Vyvanse
- Measurement of ventral prefrontal, striatal, and amygdala brain activation, assessed using food cues. [ Time Frame: Change from baseline to 12 weeks of brain activation ]Investigators will statistically compare the brain response to food pictures of BED patients before and after receiving 12 weeks of LDX treatment.
- Clinical Global Impression Improvement Scale (CGI-I) [ Time Frame: weeks 1, 2, 3, 4, 6, 8, 10, 12 ]score between 1-7 (1 = very much improved, ranging to 7 = very much worse)
- Yale Brown Obsessive-Compulsive Scale modified for binge eating (YBOC-BE) [ Time Frame: weeks 0,1, 2, 3, 4, 6, 8, 10, 12 ]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.
- Binge Eating Scale (BES) [ Time Frame: weeks 0,1, 2, 3, 4, 6, 8, 10, 12 ]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.
- Weight [ Time Frame: weeks 0,1, 2, 3, 4, 6, 8, 10, 12 ]measured in kilograms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659488
|Contact: Anna Guerdjikova, PhD, LISWemail@example.com|
|United States, Ohio|
|Lindner Center of HOPE||Recruiting|
|Mason, Ohio, United States, 45040|
|Contact: Anna Guerdjikova, PhD,LISW 513-536-0700|
|Principal Investigator: Susan L. McElroy, MD|
|Principal Investigator:||Susan L McEroy, MD||Lindner Center of HOPE|