Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder (BED)

• Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks [ Time Frame: Baseline and up to 11 weeks ] [ Designated as safety issue: No ]
  The number of binge episodes per week as assessed by clinical interview based on subject diary.
• 1-Week Binge Response, Last Observation Carried Forward (LOCF) [ Time Frame: Last 7 days on study ] [ Designated as safety issue: No ]
  The 1-week binge response was defined as either a 1-week remission (a 100% reduction of binge episodes from baseline [ie, a cessation of binge eating behavior]), or a marked response (75 to <100% reduction in binge episodes from baseline), or a moderate response (50 to <75% reduction in binge episodes from baseline), or a negative/minimal response (<50% reduction in binge episodes from baseline). The 1-week response was determined at the end of the study utilizing a LOCF approach.
• 4-Week Binge Response, Last Observation Carried Forward [ Time Frame: Last 28 days on study ] [ Designated as safety issue: No ]
  Subjects are free from binge episodes for 4 weeks.
• Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
• Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
• Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks [ Time Frame: Up to 11 weeks ] [ Designated as safety issue: No ]
  Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
• Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
  The YBOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. A score of 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; and 32-40 is extreme.
• Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
  MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
• Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
  The HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe, and 31-56 severe anxiety.
• Change From Baseline in Eating Inventory Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
  The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior: cognitive restraint of eating, disinhibition, and hunger. Cognitive restraint of eating consists of 20 items, disinhibition consists of 16 items, and hunger consists of 15 items. Each item scores either 0 or 1 point for a total score of 0-20 for cognitive restraint of eating, 0-16 for disinhibition, and 0-15 for hunger. A higher score is better for cognitive restraint of eating and lower scores are better for disinhibition and hunger.
• Change From Baseline in Binge Eating Scale (BES) Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
  The BES is a 16-item self-reported questionnaire that is designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. The items are summed, with possible scores ranging from 0 to 46. A score of 27 or higher indicates severe binge-eating problems, and a score of 17 or lower designates no binge-eating problems.
• Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
  The BIS-11 is a self-reported 30-item questionnaire that measures impulsiveness using a 4-point Likert scale (rarely/never = 1, occasionally = 2, often = 3, almost always/always = 4). A Total Impulsivity score is calculated by summing the scores for each item. Possible scores range from 30 - 120. Higher scores indicate increased impulsiveness.
• Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
  The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. There are 8 subscales. Four of the subscales has one-item each; the other 4 have two-items each. For each subscale, a mean value was first computed and transformed to a position on a scale ranging from 0-100 (Z-transformation). The aggregate total scores are then transformed into a mean value ranging from 0 (lowest level of health) to 100 (highest level of health).

• Clinical Global Impressions (CGI) Rating Scale Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
• Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
• Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
• Hamilton Anxiety Rating Scale (HAM-A) Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
• Three-Factor Eating Questionnaire (TFEQ) Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
• Binge Eating Scale (BES) Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
• Barratt Impulsiveness Scale (BIS-11) Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
• Short Form-12 Health Survey (SF-12) Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]

To evaluate the efficacy of SPD489 compared to placebo in the treatment of moderate to severe binge eating disorder as measured by the number of binge days per week

• Drug: lisdexamfetamine dimesylate (SPD489)
  SPD489-30mg capsules taken once daily for up to 11 weeks
  Other Name: LDX, Vyvanse
• Drug: lisdexamfetamine dimesylate (SPD489)
  SPD489 50mg capsules taken once-daily for up to 11 weeks
  Other Name: LDX, Vyvanse
• Drug: lisdexamfetamine dimesylate (SPD489)
  SPD489 70mg capsule taken once-daily for up to 11 weeks
  Other Name: LDX, Vyvanse
• Drug: Placebo
  Placebo capsule taken once daily for up to 11 weeks

• Experimental: SPD489 30 mg
  Intervention: Drug: lisdexamfetamine dimesylate (SPD489)
• Experimental: SPD489 50 mg
  Intervention: Drug: lisdexamfetamine dimesylate (SPD489)
• Experimental: SPD489 70 mg
  Intervention: Drug: lisdexamfetamine dimesylate (SPD489)
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

Inclusion

• Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of binge eating disorder (BED).
• Binge eating disorder is of at least moderate severity in which subjects report at least 3 binge eating days per week.
• Subject has a body mass index (BMI) of >24 and <46.

Exclusion

• Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
• Subject is considered a suicide risk or risk to harm others.