Phase 3
Completed N=150
Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT00428792 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population — 0.97; 1.01 Units on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population |
0.97; 1.01 | — |
| PRIMARY Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population |
0.93; 1.0 | — |
| SECONDARY Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating |
1.19; 1.23 | — |
| SECONDARY Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating |
0.72; 0.75 | — |
| SECONDARY Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating |
0.93; 0.99 | — |
| SECONDARY Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating |
1.15; 1.11 | — |
| SECONDARY 10-Minute Math Test - Problems Attempted |
116.3; 118.1 | — |
| SECONDARY 10-Minute Math Test - Problems Solved |
106.7; 108.6 | — |
| SECONDARY Clinical Global Impression Severity (CGI-S) Scale Score - Physician Rating of Severity |
2.75; 2.74 | — |
| SECONDARY Clinical Global Impression (CGI-I) Scale Score - Physician Rating of Improvement (Change in State) |
3.49; 3.56 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00428792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.