Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD methylphenidate children food effect Attention-Deficit Hyperactivity Disorder (ADHD) in children
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 150
Healthy volunteers: no

Brief summary:
This study evaluated the safety and clinical effect of treatment with methylphenidate under different breakfast conditions (minimal breakfast versus standard continental breakfast) in children with Attention-Deficit Hyperactivity Disorder (ADHD).

Detailed description:

Arms:
arm 1: Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 1 or 2 20 mg capsules of methylphenidate once per day based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. arm 2: Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 1 or 2 20 mg capsules of methylphenidate once per day based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.

Interventions: intervention 1: Methylphenidate 20 mg long-acting capsules
Intervention descriptions: intervention 1: None

Protocol document: