Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
Keywords: ADHD, children, subjects, laboratory classroom
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 165
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in a 12-hour laboratory classroom setting.

Detailed description:

Arms:
arm 1: Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg dose (one 20 mg capsule and one 10 mg capsule) orally once a day for 7 days. arm 2: Dex-Methylphenidate hydrochloride (Focalin® XR) one 20 mg capsule orally once a day for 7 days. arm 3: Two Capsules taken orally once a day for 7 days

Interventions: intervention 1: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR) intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg and/or 20 mg capsules intervention 2: Placebo Comparator

Protocol document: