This study will test the effectiveness of lisdexamfetamine medication as a treatment for loss-of-control eating and weight following bariatric surgery. This is a controlled test of whether, amongst non-responders to acute treatments, lisdexamfetamine medication results in superior outcomes compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
Medication will be taken daily in pill form.
Placebo will be inactive and taken daily in pill form.
Yale School of Medicine
New Haven, Connecticut, United States
Loss-of-Control Eating Frequency
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Time frame: At the end of 12-week treatment
Loss-of-Control Eating Frequency
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Time frame: 6-month follow-up from the end of treatment
Loss-of-Control Eating Frequency
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Time frame: 12-month follow-up from the end of treatment
Percent Weight Change
Percent weight loss is calculated based on change from pre-treatment to post-treatment at 3 months. Negative values indicate weight loss.
Time frame: From baseline at study enrollment to after the 12-week treatment
Percent Weight Change
Percent weight loss is calculated based on change from post-treatment to the 6-month follow-up. Negative values indicate weight loss.
Time frame: From post-treatment to the 6-month follow-up
Percent Weight Change
Percent weight loss is calculated based on change from post-treatment to the 12-month follow-up. Negative values indicate weight loss.
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Time frame: From post-treatment to the 12-month follow-up