Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 123
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the maintenance of efficacy, as measured by Adult ADHD Rating Scale with Prompts (Adult ADHD-RS with prompts) and Clinical Global Impression - Severity (CGI-S) scores, through a randomized withdrawal design when subjects with ADHD have been on stable treatment with commercial SPD489 for a minimum of 6 months and are maintained on their screening dose of commercial SPD489.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: SPD489 (Lisdexamfetamine dimesylate) intervention 2: Placebo
Intervention descriptions: intervention 1: 1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks. intervention 2: 1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period.

Protocol document: