Conditions: Binge Eating Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 383
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: SPD489 (Lisdexamfetamine dimesylate) intervention 2: Placebo
Intervention descriptions: intervention 1: 50 or 70 mg administered orally, once-daily for up to 12 weeks intervention 2: Administered once-daily, orally, for up to 12 weeks

Protocol document: