At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 150 enrolled
Drug / intervention
Methylphenidate 20 mg long-acting capsulesdrug
Likely dose
Methylphenidate 20–40 mg orally once daily (immediate-release or extended-release)AI-extracted
Key inclusion· 3
- ✓Age 6–12 years
- ✓Confirmed diagnosis of ADHD
- ✓Currently treated with 20 mg or 40 mg immediate-release methylphenidate
Key exclusion· 7
- ✕Concomitant psychiatric disorders requiring pharmacological treatment
- ✕Concomitant severe somatic disorders
- ✕Eating disorders
- ✕Addiction disorders
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Methylphenidate 20 mg long-acting capsules for Attention Deficit Hyperactivity Disorder. Completed, enrolled 150 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesGermany
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2007
Enrollment StartApr 2007
Primary CompletionDec 2007
TodayJul 2026
First PostedJan 30, 2007
Enrollment StartApr 1, 2007
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 19.4 years ago
Interventions
Methylphenidate 20 mg long-acting capsulesdrug