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

Novartis

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Methylphenidate 20 mg long-acting capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT00428792

CRIT124DDE04

Details and patient eligibility

About

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).

Enrollment: 150 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Very light breakfast (VLB) then standard breakfast (SB)

Experimental group

Description:

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.

Treatment:

Drug: Methylphenidate 20 mg long-acting capsules

Standard breakfast (SB) then very light breakfast (VLB)

Experimental group

Description:

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.

Treatment:

Drug: Methylphenidate 20 mg long-acting capsules