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: 390.0
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:

        The subject cannot be enrolled in the study before all of the following inclusion criteria
        (including test results) are met:

          1. Subject is between 18-55 years of age.

          2. Subject meets the following Diagnostic and Statistical Manual of Mental Disorders
             Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED:

          3. Subject has a BED diagnosis.

          4. Subject's BED is of at least moderate severity with subjects reporting at least 3
             binge eating days per week.

          5. Female subjects must have a negative serum B-HCG pregnancy test and a negative urine
             pregnancy test and agree to comply with any applicable contraceptive requirements.

        Exclusion Criteria:

        Subjects are excluded from the study if any of the following exclusion criteria are met:

          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.

          3. Subject has used psychostimulants to facilitate fasting or dieting as a part of their
             BED.

          4. Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.

          5. Subject is considered a suicide risk, has previously made a suicide attempt, or is
             currently demonstrating active suicidal ideation.

          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 a history of moderate or severe hypertension.

          8. Subject is female and pregnant or nursing.

          9. Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for
             weight loss.