This 6-week study is to determine if the study drug, Methylphenidate Hydrochloride (HCl) Extended-Release Chewable Tablets (ERCT), is safe, tolerable and effective when compared to a sugar pill or placebo in children 4 to 5 years of age with ADHD.
Phase 4 Double-blind, Randomized, Parallel Group, Placebo-controlled Study of the Efficacy And Safety of Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablets (ERCT) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
Placebo
Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version
Change from Baseline to end of double-blind treatment in the total score of the Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version
Time frame: Basline, 6 Weeks
Safety-incidence of treatment emergent adverse events
incidence of treatment emergent adverse events
Time frame: 6 Weeks
Change from Baseline in Clinical Global Impression - Severity (CGI-S) score
The CGI-S is a one-item scale for the clinician to assess their impression of the severity of a subject's current state of illness relative to clinician's past experience with patients who have the same diagnosis. A subject's severity of mental illness is assessed considering a clinician's total clinical experience using a scale from 1 to 7 defined as: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.
Time frame: Baseline, Weeks 1 through 6
Change from Baseline in Clinical Global Impression of Improvement (CGI-I) Scale Score
The CGI-I is a one-item scale to compare the subject's current condition to the condition at the Baseline (Day -1) visit using a scale from 1 to 7 defined as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
Time frame: Baseline, Weeks 1 through 6
ADHD RS-IV Preschool-Home Version Total score
The ADHD RS-IV Preschool Version is an 18-item scale corresponding to the 18 items in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria that is divided into 2 subscales: hyperactivity/impulsivity and inattentiveness. Each item is scored on a 4-point scale ranging from 0 = never/rarely to 3 = very often.
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Time frame: Weeks 1 through 5
ADHD RS-IV Preschool-Home Version hyperactivity and inattention subscales scores
The ADHD RS-IV Preschool Version is an 18-item scale corresponding to the 18 items in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria that is divided into 2 subscales: hyperactivity/impulsivity and inattentiveness. Each item is scored on a 4-point scale ranging from 0 = never/rarely to 3 = very often.
Time frame: Weeks 1 through 6
ADHD RS-IV Preschool-School Version Total score
The ADHD RS-IV Preschool - School Version will be completed by the subject's teacher.
Time frame: Weeks 3 and 6
ADHD RS-IV Preschool-School Version hyperactivity and inattention subscales scores
The ADHD RS-IV Preschool - School Version will be completed by the subject's teacher.
Time frame: Weeks 3 and 6