Phase 4
Completed N=89
CONCERTA Lab School Study
Source: ClinicalTrials.gov NCT00799487 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Oct 2010
Primary outcomePrimary: Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted) — 88.0; 116.1 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) |
88.0; 116.1 | <0.0001 sig |
| PRIMARY Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct) |
84.0; 112.8 | <0.0001 sig |
| SECONDARY Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment) |
8.0; 3.1 | <0.0001 sig |
| SECONDARY Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention) |
10.1; 5.6 | <0.0001 sig |
| SECONDARY Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite) |
18.1; 8.7 | <0.0001 sig |
| SECONDARY Hour 5.5 Test of Variables of Attention (TOVA) ADHD Score |
-4.19; -0.68 | <0.0001 sig |
| SECONDARY Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time (Msec) |
75.23; 93.21 | <0.0001 sig |
| SECONDARY Hour 5.5 Test of Variables of Attention(TOVA) Reaction Time Variability (Standard Deviation in Milliseconds (Msecs)) |
56.58; 87.22 | <0.0001 sig |
| SECONDARY Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards |
9.8; 10.9 | 0.0297 sig |
| SECONDARY Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards |
12.3; 13.2 | 0.0955 |
| SECONDARY Hour 5.5 Test of Variables of Attention (TOVA) Commissions |
78.35; 90.54 | 0.0002 sig |
| SECONDARY Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards |
4.8; 5.1 | 0.2335 |
| SECONDARY Hour 8.75 Gray Silent Reading Test (GSRT) |
89.1; 92.1 | 0.2321 |
| SECONDARY Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) |
79.1; 82.7 | 0.0015 sig |
| SECONDARY Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS) |
110.8; 117.8 | 0.0101 sig |
| SECONDARY Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards |
8.4; 8.5 | 0.6642 |
| SECONDARY Hour 5.5 Test of Variables of Attention (TOVA) Omissions |
36.34; 71.49 | 0.0040 sig |
| SECONDARY Hour 3.0 Grammar Task |
0.252; 0.340 | 0.0012 sig |
| SECONDARY Hour 8.75 Packet Activity - Short Story With Questions for Comprehension |
0.619; 0.699 | 0.0051 sig |
| SECONDARY Hour 8.75 Packet Activity - Identiy Root Word |
0.580; 0.638 | 0.1768 |
| SECONDARY Hour 8.75 Packet Activity - Alphabetize List of Words |
0.638; 0.660 | 0.4245 |
| SECONDARY Hour 8.75 Packet Activity - Identify Multiple Meanings for Words |
0.814; 0.821 | 0.9729 |
| SECONDARY Hour 8.75 Packet Activity - Complete Sentences Using Words Provided |
0.730; 0.781 | 0.3486 |
| SECONDARY Hour 8.75 Packet Activity - Word Search |
0.955; 0.984 | 0.1466 |
| SECONDARY Hour 8.75 Packet Activity - Decode the Mystery Sentence |
0.989; 0.955 | 0.1368 |
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 (NCT00799487). 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.