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

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: methylphenidate long-acting (LA) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharma, Study Chair, Affiliation: Novartis

This study will evaluate the safety and clinical effect of treatment with methylphenidate under different breakfast conditions (minimal breakfast versus standard continental breakfast) in children with ADHD.

Official title: 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 o.d.) in Children With ADHD Under Different Breakfast Conditions Over Two Weeks

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study

Primary outcome: Validated questionnaire about core ADHD symptoms (Fremdbeobachtungsskala-Aufmerksamkeitsdefizit-Hyperaktivitätssyndrom, FBB-AHDS) filled out by a teacher after one week and two weeks

Secondary outcome:

Validated questionnaire about core ADHD symptoms filled out by parents after one week and two weeks

Clinical global impression rated by treating physician after one week, two weeks and at closeout

Math test (number of maths problems attempted and number of correctly solved math problems) at baseline, after one and two weeks

Detailed description: This study will evaluate the safety and clinical effect of treatment with methylphenidate under different breakfast conditions (minimal breakfast versus standard continental breakfast) in children with ADHD.

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Children aged 6-12

- Diagnosis of 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 may apply

Novartis Investigative Site, Freiburg, Germany

Starting date: April 2007
Ending date: December 2007
Last updated: December 19, 2007