Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)

An Open-label, Randomized, Rater-blinded, Cross-over, Multicenter Study Comparing the Clinical Efficacy of Methylphenidate (Immediate Release/Extended Release) Treatment (20 or 40 mg Orally od) in Children With Attention-Deficit Hyperactivity Disorder (ADHD) Under Different Breakfast Conditions Over Two Weeks

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).

Inclusion Criteria:

• Children aged 6-12
• Diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD)
• Current medication with either 20 mg or 40 mg immediate release methylphenidate

Exclusion Criteria:

• Concomitant psychiatric disorders requiring pharmacological treatment
• Concomitant severe somatic disorders
• Eating disorders
• Addiction disorders
• Very high or low body weight according to age
• Known hypersensitivity to methylphenidate
• Contraindications for methylphenidate

Other protocol-defined inclusion/exclusion criteria applied to the study.