This study will test the effectiveness of lisdexamfetamine (LDX) medication as a maintenance therapy for the treatment of binge-eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, LDX medication results in superior maintenance and longer-term outcomes compared with placebo.
Obesity is a heterogeneous problem and research has highlighted the particular significance of a subgroup with binge-eating disorder (BED), the most prevalent formal eating disorder. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (maintenance stage) RCT will provide findings from a controlled test, amongst responders to acute treatments, whether LDX medication results in superior maintenance and longer-term outcomes than placebo. This is one of the few RCTs for BED of medication with follow-up after medication discontinuation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
61
Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Yale Department of Psychiatry
New Haven, Connecticut, United States
Binge-Eating Relapse
Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of binge-eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 binge-eating episodes per month.
Time frame: 12 weeks
Binge-Eating Relapse
Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of binge-eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 binge-eating episodes per month.
Time frame: 6-month follow-up
Binge-Eating Relapse
Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of binge-eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 binge-eating episodes per month.
Time frame: 12 month follow-up
Change in Binge-Eating Frequency
Binge-eating frequency is a continuous variable of binge-eating episodes assessed using the Eating Disorder Examination interview; Binge-eating frequency will be based on the past 28 days and defined as binge-eating episodes per month.
Time frame: From baseline interview at study enrollment to 3 months after the 12-week treatment
Change in Binge-Eating Frequency
Binge-eating frequency is a continuous variable of binge-eating episodes assessed using the Eating Disorder Examination interview; Binge-eating frequency will be based on the past 28 days and defined as binge-eating episodes per month.
Time frame: From post-treatment to the 6-month follow-up
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Change in Binge-Eating Frequency
Binge-eating frequency is a continuous variable of binge-eating episodes assessed using the Eating Disorder Examination interview; Binge-eating frequency will be based on the past 28 days and defined as binge-eating episodes per month.
Time frame: From post-treatment to the 12-month follow-up
Change in Eating-Disorder Psychopathology (Continuous)
Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Time frame: From baseline interview at study enrollment to 3 months after the 12-week treatment
Change in Eating-Disorder Psychopathology (Continuous)
Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Time frame: From post-treatment to the 6-month follow-up
Change in Eating-Disorder Psychopathology (Continuous)
Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Time frame: From post-treatment to the 12-month follow-up
Change in Depressive Symptoms
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms).
Time frame: From baseline interview at study enrollment to 3 months after the 12-week treatment
Change in Depressive Symptoms
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms).
Time frame: From post-treatment to the 6-month follow-up
Change in Depressive Symptoms
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms).
Time frame: From post-treatment to the 12-month follow-up
Percent Change in Weight
Negative values indicate weight loss and positive values indicate weight gain.
Time frame: From baseline interview at study enrollment to 3 months after the 12-week treatment
Percent Change in Weight
Negative values indicate weight loss and positive values indicate weight gain.
Time frame: From post-treatment to the 6-month follow-up
Percent Change in Weight
Negative values indicate weight loss and positive values indicate weight gain.
Time frame: From post-treatment to the 12-month follow-up