SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Intervention: SPD489 (Lisdexamfetamine dimesylate); Placebo
Intervention description: 50 or 70 mg administered orally, once-daily for up to 12 weeks; Administered once-daily, orally, for up to 12 weeks
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 383.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to demonstrate the efficacy of SPD489 compared with
      placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating
      Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as
      days during which at least 1 binge episode occurs) per week as assessed by clinical interview
      based on subject diary
    

Eligibility criteria:

        Inclusion Criteria -

          1. Subject is between 18-55 years of age.

          2. Subject meets the following DSM-IV-TR criteria for a diagnosis of BED:

             Recurrent episodes of binge eating. An episode of binge eating is characterized by
             both of the following: eating, in a discrete period of time (eg, within a 2-hour
             period) an amount of food that is definitely larger than most people would eat in a
             similar period of time under similar conditions, and a sense of lack of control over
             the eating (eg, a feeling that one cannot stop eating or control what or how much one
             is eating).

             The binge eating episodes are associated with at least 3 of the following: eating much
             more rapidly than normal; eating until uncomfortably full; eating large amounts of
             food when not feeling physically hungry; eating alone because of being embarrassed by
             how much one is eating; feeling disgusted with oneself, depressed, or feeling very
             guilty after overeating.

             Marked distress regarding binge eating. The binge eating occurs, on average, at least
             2 days a week for 6 months. The episodes of binge eating do not occur exclusively
             during the course of bulimia nervosa or anorexia nervosa.

          3. Subject's BED is of at least moderate severity with subjects reporting at least 3
             binge eating days per week for the 14 days prior to the Baseline Visit (Visit 0) as
             documented in the subject's binge diary. A binge day is a day during which at least 1
             binge eating episode occurs.

          4. Female subjects must have a negative serum B HCG pregnancy test and a negative urine
             pregnancy test.

        Exclusion Criteria-

          1. Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.

          2. Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior
             therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED
             within 3 months.

          3. Subject has used psychostimulants to facilitate fasting or dieting as a part of their
             BED within 6 months.

          4. Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.

          5. Subject is considered a suicide risk in the opinion of the investigator, has
             previously made a suicide attempt, or is currently demonstrating active suicidal
             ideation. Subjects with intermittent passive suicidal ideation are not necessarily
             excluded based on the assessment of the investigator.

          6. Subject has known history of symptomatic cardiovascular disease, advanced
             arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm
             abnormalities, coronary artery disease, or other serious cardiac problems.

          7. Subject has recently initiated treatment with a lipid-lowering medication (within the
             past 3 months).

          8. Subject has a history of moderate or severe hypertension.

          9. Subject is female and pregnant or nursing.

         10. Subjects who have had bariatric surgery, lap bands, duodenal stents, or other
             procedures for weight loss.