Phase 4
Completed N=78
Lab School Day Study for CONCERTA of Older Children With ADHD
Source: ClinicalTrials.gov NCT00799409 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcomePrimary: Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted) — 74.8; 103.5 Problems attempted — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted) |
74.8; 103.5 | <0.0001 sig |
| PRIMARY Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct) |
69.0; 97.4 | <0.0001 sig |
| SECONDARY Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment) |
9.0; 3.1 | <0.0001 sig |
| SECONDARY Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention) |
11.8; 6.7 | <0.0001 sig |
| SECONDARY Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite) |
20.8; 9.9 | <0.0001 sig |
| SECONDARY Hour 5.5 Test of Variables of Attention (TOVA) ADHD Composite Cutoff Score |
-4.39; -1.34 | <0.0001 sig |
| SECONDARY Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Standard Score |
73.80; 89.72 | <0.0001 sig |
| SECONDARY Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Variability Standard Score |
62.87; 85.14 | <0.0001 sig |
| SECONDARY Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards |
11.2; 12.2 | 0.1800 |
| SECONDARY Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards |
12.9; 14.3 | 0.0057 sig |
| SECONDARY Hour 5.5 Test of Variables of Attention (TOVA) Commissions Standard Score |
86.42; 92.58 | 0.1091 |
| SECONDARY Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards |
5.1; 5.4 | 0.2653 |
| SECONDARY Hour 8.75 Gray Silent Reading Test (GSRT) Reading Quotient |
85.9; 91.9 | 0.0038 sig |
| SECONDARY Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) Standard Score |
93.6; 98.3 | 0.0001 sig |
| SECONDARY Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS) |
106.2; 112.0 | 0.0092 sig |
| SECONDARY Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards |
9.2; 9.3 | 0.9195 |
| SECONDARY Hour 5.5 Test of Variables of Attention (TOVA) Omissions Standard Score |
25.98; 64.07 | 0.0002 sig |
| SECONDARY Hour 3.0 Grammar Task |
0.241; 0.327 | 0.0002 sig |
| SECONDARY Hour 8.75 Packet Activity Short Story With Questions for Comprehension |
0.609; 0.629 | 0.4625 |
| SECONDARY Hour 8.75 Packet Activity Identify Root Word |
0.744; 0.760 | 0.6262 |
| SECONDARY Hour 8.75 Packet Activity Alphabetize List of Words |
0.676; 0.676 | 0.9980 |
| SECONDARY Hour 8.75 Packet Activity Identify Multiple Meanings for Words |
0.694; 0.795 | 0.0151 sig |
| SECONDARY Hour 8.75 Packet Activity Complete Sentences Using Words Provided |
0.652; 0.741 | 0.0043 sig |
| SECONDARY Hour 8.75 Packet Activity Word Search |
0.935; 0.979 | 0.0371 sig |
| SECONDARY Hour 8.75 Packet Activity Decode the Mystery Sentence |
0.960; 0.987 | 0.0965 |
Eligibility 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.
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.
Data sourced from ClinicalTrials.gov (NCT00799409). 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.