Clinical trial NCT00428792: Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (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 od) in Children With Attention-Deficit Hyperactivity Disorder (ADHD) Under Different Breakfast Conditions Over Two Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
methylphenidate
children
food effect
Attention-Deficit Hyperactivity Disorder (ADHD) in children
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-30
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).


Eligibility 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.

Primary outcomes:
measure: Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population
timeFrame: Friday of each of the 2 treatment weeks
measure: Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population
timeFrame: Friday of each of the 2 treatment weeks
Secondary outcomes:
measure: Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating
timeFrame: Friday of each of the 2 treatment weeks
measure: Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating
timeFrame: Friday of each of the 2 treatment weeks
measure: Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating
timeFrame: Friday of each of the 2 treatment weeks
measure: Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating
timeFrame: Saturday of each of the 2 treatment weeks
measure: 10-Minute Math Test - Problems Attempted
timeFrame: Saturday of each of the 2 treatment weeks
measure: 10-Minute Math Test - Problems Solved
timeFrame: Saturday of each of the 2 treatment weeks
measure: Clinical Global Impression Severity (CGI-S) Scale Score - Physician Rating of Severity
timeFrame: Saturday of each of the 2 treatment weeks
measure: Clinical Global Impression (CGI-I) Scale Score - Physician Rating of Improvement (Change in State)
timeFrame: Saturday of each of the 2 treatment weeks
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma
role: STUDY_CHAIR
References: