At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 89 enrolled
Drug / intervention
CONCERTA (methylphenidate HCl) or placebo +1 moredrug
Likely dose
CONCERTA (methylphenidate HCl) or placebo 18mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral and Cognitive Effects of CONCERTA on Older Children With ADHD (The ABC Study)
In Brief
A Phase 4 clinical trial evaluating CONCERTA (methylphenidate HCl) or placebo for Attention Deficit Hyperactivity Disorder. Completed, enrolled 89 participants across 3 sites.
Detailed Summary
The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2008
Enrollment StartJan 2009
Primary CompletionJun 2009
TodayJul 2026
First PostedDec 1, 2008
Enrollment StartJan 2, 2009
Primary CompletionJun 26, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.6 years ago
Interventions
CONCERTA (methylphenidate HCl) or placebodrug
Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #1 with placebo on Day #2
CONCERTA (methylphenidate HCl) or placebodrug
Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #2 with placebo on Day #1