Attention Deficit Hyperactivity Disorder MedDRA version: 18.0 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder System Organ Class: 100000004873
Conditions
Sponsors
Ortho-McNeil Janssen Scientific Affairs LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - ADHD diagnosis of all subtypes (except Not Otherwise Specified) - Patients with total or subscale Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS-IV) scores > =90th percentile relative to the general population of children by age and gender - Patients currently receiving ADHD medication must be inadequately managed on their current stimulant dose and meet this criteria at the screening visit - Ability to read and understand English - Ability to attend school regularly Are the trial subjects under 18? yes Number of subjects for this age range: 89 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Estimated Full Scale IQ score of 80 or below, Severe Learning Disability - History of or current, primary diagnosis of: severe anxiety disorder, conduct disorder, psychotic disorders, Pervasive Developmental Disorder, Eating Disorder, Obsessive-Compulsive Disorder, Sleep Disorder, Major Depressive Disorder, Bipolar Disorder, Substance Use Disorder, Chronic Tic Disorder, personal or family history of Tourette's Syndrome - Weight < 3rd percentile for age - History of hospitalization for treatment of a mood, anxiety, or psychotic disorder - History of failed response to methylphenidate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): - Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted) - Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct) ;Timepoint(s) of evaluation of this end point: At the Hour stated above of the of the Lab School Day during Double-Blind Assessment Period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment) - Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention) - Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite) - Hour 5.5 Test of Variables of Attention (TOVA) ADHD Score - Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time (msec) - Hour 5.5 Test of Variables of Attention(TOVA) Reaction Time Variability (Standard Deviation in milliseconds (msecs)) - Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards - Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards - Hour 5.5 Test of Variables of Attention (TOVA) Commissions - Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards - Hour 8.75 Gray Silent Reading Test (GSRT) - Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) - Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS) - Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards - Hour 5.5 Test of Variables of Attention (TOVA) Omissions - Hour 3.0 Grammar Task - Hour 8.75 Packet Activity - Short Story with Questions for Comprehension - Hour 8.75 Packet Activity - Identiy Root Word - Hour 8.75 Packet Activity - Alphabetize list of words - Hour 8.75 Packet Activity - Identify multiple meanings for words - Hour 8.75 Packet Activity - Complete sentences using words provided - Hour 8.75 Packet Activity - Word search - Hour 8.75 Packet Activity - Decode the mystery sentence ;Timepoint(s) of evaluation of this end point: At the Hour stated above of the of the Lab School Day during Double-Blind Assessment Period | — |
Countries
United States
Contacts
Public ContactClinical Registry Group-JB BV
Janssen Research and Development
Outcome results
None listed