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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

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.

Group Type EXPERIMENTAL

Methylphenidate 20 mg long-acting capsules

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Methylphenidate 20 mg long-acting capsules

Intervention Type DRUG

Interventions

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Methylphenidate 20 mg long-acting capsules

Intervention Type DRUG

Other Intervention Names

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Ritalin LA

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No