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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Methylphenidate

Criteria

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.