Evaluate the Maintenance of Efficacy of 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: Lisdexamfetamine dimesylate; Placebo
Intervention description: SDP489 30, 50, or 70mg capsule once per day (open-label and double-blind periods); Placebo capsule once per day (double-blind period)
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 418.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and
      placebo, 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 and
      Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by
      the end of the Open-label Treatment Phase.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is between 18-55 years of age, inclusive.

          2. Subject meets the following 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 is consistently able to swallow a capsule.

        Exclusion Criteria:

          1. Subject has current diagnosis of bulimia nervosa or anorexia nervosa.

          2. Subject is receiving psychotherapy or weight loss support within the past 3 months.

          3. Subject has used psychostimulants to facilitate fasting or dieting within the past 6
             months.

          4. Subject has known history of symptomatic cardiovascular disease, advanced
             arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm
             abnormalities, coronary artery disease.

          5. Subject has abnormal thyroid function.

          6. Subject initiated treatment with a lipid lowering medication within the past 3 months.

          7. Subject has a history of moderate or severe hypertension.

          8. Subject has a recent history (within the past 6 months) of suspected substance abuse
             or dependence disorder.

          9. Subject has glaucoma.

         10. Subject is female and pregnant or nursing.

         11. Subjects who have had bariatric surgery, lap bands, duodenal stents, or other
             procedures for weight loss.