Conditions: Binge Eating Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 418
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Administer one capsule (50 or 70 mg) orally daily at approximately 7:00 AM. arm 2: Administer one capsule orally daily at approximately 7:00 AM.

Interventions: intervention 1: Lisdexamfetamine dimesylate intervention 2: Placebo
Intervention descriptions: intervention 1: SDP489 30, 50, or 70mg capsule once per day (open-label and double-blind periods) intervention 2: Placebo capsule once per day (double-blind period)

Protocol document: