Clinical Trial Results:
A Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral, and Cognitive Effects of CONCERTA on Older Children with ADHD
Due to a system error, the data reported in v1 is not correct and has been removed from public view.
Summary
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EudraCT number |
2015-001081-26 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
12 Jun 2009
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Results information
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Results version number |
v2(current) |
This version publication date |
01 Jul 2016
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First version publication date |
31 Jul 2015
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Other versions |
v1 (removed from public view) |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CONCERTAATT4069
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00799409 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Ortho-McNeil Janssen Scientific Affairs LLC
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Sponsor organisation address |
1125 Trenton-Harbourton Road, Titusville, New Jersey, United States, 08560- 0200
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Public contact |
Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 Jun 2009
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Jun 2009
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
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.
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Protection of trial subjects |
Safety were evaluated throughout the study by monitoring of adverse events (AEs), laboratory tests (complete blood count [CBC], complete chemistry panel, and liver function tests [LFTs]), vital signs body weight measurements, electrocardiogram and the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL) including items specifically examining suicidal thinking.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
17 Nov 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 78
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Worldwide total number of subjects |
78
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
67
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Adolescents (12-17 years) |
11
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||
Pre-assignment
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Screening details |
Total 78 subjects were enrolled in the study and out of 78 only only 71 subjects completed the study. | ||||||||||||||
Period 1
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Period 1 title |
Open-Label Dose Adjustment Period
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Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||
Arms
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Arm title
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Concerta | ||||||||||||||
Arm description |
Subjects initiated with Concerta as 18 milligram/day (mg/day) once daily. Concerta dose was continuously increased until an optimal individualized dose was achieved, up to a maximum dose of 54 mg/day. | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Concerta
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Concerta (18 mg, 36 mg, or 54 mg) tablet once daily orally was administered.
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Period 2
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Period 2 title |
Double-Blind Assessment Period
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Is this the baseline period? |
No | ||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo/Concerta | ||||||||||||||
Arm description |
Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18 mg, 36 mg, or 54 mg tablet) once daily at lab school Day 2. | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subject received placebo matching with Concerta orally once daily
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Investigational medicinal product name |
Concerta
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Concerta (18mg, 36mg, or 54 mg) orally tablet was given once daily
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Arm title
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Concerta/Placebo | ||||||||||||||
Arm description |
Children randomized to receive an individualized, optimal dose of Concerta (18 mg, 36 mg, or 54 mg tablet) once daily at lab school Day 1 and Placebo at lab school Day 2. | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Concerta
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Concerta (18mg, 36mg, or 54 mg) orally tablet was given once daily.
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subject received placebo matching with Concerta orally once daily
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Baseline characteristics reporting groups
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Reporting group title |
Open-Label Dose Adjustment Period
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Reporting group description |
Subjects initiated with Concerta as 18 milligram/day (mg/day) once daily. Concerta dose was continuously increased until an optimal individualized dose was achieved, up to a maximum dose of 54 mg/day. | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Concerta
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Reporting group description |
Subjects initiated with Concerta as 18 milligram/day (mg/day) once daily. Concerta dose was continuously increased until an optimal individualized dose was achieved, up to a maximum dose of 54 mg/day. | ||
Reporting group title |
Placebo/Concerta
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Reporting group description |
Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18 mg, 36 mg, or 54 mg tablet) once daily at lab school Day 2. | ||
Reporting group title |
Concerta/Placebo
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Reporting group description |
Children randomized to receive an individualized, optimal dose of Concerta (18 mg, 36 mg, or 54 mg tablet) once daily at lab school Day 1 and Placebo at lab school Day 2. | ||
Subject analysis set title |
Intent-to-treat (ITT) population
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Intent-to-Treat for Placebo and Concerta columns in the primary and secondary results are comprised of the 36 children randomized to Placebo/Concerta (lab day 1/lab day 2) plus the 35 children randomized to Concerta/Placebo.
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Subject analysis set title |
Placebo
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Children randomized to receive Placebo at lab school day 1 or lab school day 2
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Subject analysis set title |
Concerta
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Children randomized to receive Concerta at lab school day 1 or lab school day 2
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End point title |
Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted) | ||||||||||||
End point description |
PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of attempted problems. A higher number of problems attempted was indicative of greater attention to detail (higher score is preferable)
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End point type |
Primary
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End point timeframe |
Hour 4 of the of the Lab School Day during Double-Blind Assessment Period
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Notes [1] - ITT Population [2] - ITT Population |
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Statistical analysis title |
Statistical Analysis 1 | ||||||||||||
Comparison groups |
Placebo v Concerta
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Number of subjects included in analysis |
142
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Analysis specification |
Pre-specified
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Analysis type |
superiority [3] | ||||||||||||
P-value |
< 0.0001 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
LS Mean Difference | ||||||||||||
Point estimate |
-28.6
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-35 | ||||||||||||
upper limit |
-22.3 | ||||||||||||
Notes [3] - Number of subjects included in the analysis were “71” instead of "142", as same subjects received both treatments (Placebo and Concerta), one in each treatment period. |
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End point title |
Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct) | ||||||||||||
End point description |
PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest performed at Visit 2. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of correct problems. A higher number of problems correct, of those attempted, was indicative of greater accuracy.
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End point type |
Primary
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End point timeframe |
Hour 4 of the Lab School Day During the Double-Blind Assessment Period
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Notes [4] - ITT Population [5] - ITT Population |
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Statistical analysis title |
Statistical Analysis 1 | ||||||||||||
Comparison groups |
Placebo v Concerta
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Number of subjects included in analysis |
142
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Analysis specification |
Pre-specified
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Analysis type |
superiority [6] | ||||||||||||
P-value |
< 0.0001 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
LS Mean Difference | ||||||||||||
Point estimate |
-28.3
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-34.4 | ||||||||||||
upper limit |
-22.2 | ||||||||||||
Notes [6] - Number of subjects included in the analysis were “71” instead of "142", as same subjects received both treatments (Placebo and Concerta), one in each treatment period. |
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End point title |
Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment) | ||||||||||||
End point description |
The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Deportment (SKAMP-D) (range: 0, 36) is a sum of ratings on 6 deportment items (interacting with other children, interacting with adults, remaining quiet, staying seated, complying with the teacher’s directions, and following the classroom rules). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.
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End point type |
Secondary
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End point timeframe |
Hour 4 of the Lab School Day During the Double-Blind Assessment Period
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Notes [7] - ITT Population [8] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention) | ||||||||||||
End point description |
The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Attention (SKAMP-A) (range: 0, 42) is a sum of the ratings on 7 attention items (getting started, sticking with tasks, attending to an activity, making activity transitions, completing assigned tasks, performing work accurately, and being neat and careful while writing or drawing). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.
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End point type |
Secondary
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End point timeframe |
Hour 4 of the Lab School Day During the Double-Blind Assessment Period
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Notes [9] - ITT Population [10] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite) | ||||||||||||
End point description |
The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. A composite score (range: 0, 78) for the SKAMP variable (13 items total) was obtained by summing the SKAMP-D and SKAMP-A subscale scores. A lower score was preferable, as a higher score represented greater behavioral impairment.
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End point type |
Secondary
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End point timeframe |
Hour 4 of the Lab School Day During the Double-Blind Assessment Period
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Notes [11] - ITT Population [12] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 5.5 Test of Variables of Attention (TOVA) ADHD Composite Cutoff Score | ||||||||||||
End point description |
The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicate better performance, lower scores indicate worse performance. Clinical interpretation: an ADHD scores of -1.80 or lower (<= -1.80) are considered not within normal limits scores above -1.80 (> -1.80) are considered inconclusive (meaning, neither like-ADHD nor like-normal).
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End point type |
Secondary
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End point timeframe |
Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
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Notes [13] - ITT Population [14] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Standard Score | ||||||||||||
End point description |
The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.
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End point type |
Secondary
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End point timeframe |
Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
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Notes [15] - ITT Population [16] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Variability Standard Score | ||||||||||||
End point description |
The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.
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End point type |
Secondary
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End point timeframe |
Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
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Notes [17] - ITT Population [18] - ITT Population |
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Statistical analysis title |
Statistical Analysis 1 | ||||||||||||
Comparison groups |
Placebo v Concerta
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Number of subjects included in analysis |
142
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.0001 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
LS Mean Difference | ||||||||||||
Point estimate |
-22.45
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-27.43 | ||||||||||||
upper limit |
-17.47 |
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End point title |
Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
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Notes [19] - ITT Population [20] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards | ||||||||||||
End point description |
WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.
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End point type |
Secondary
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End point timeframe |
Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
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Notes [21] - ITT Population [22] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 5.5 Test of Variables of Attention (TOVA) Commissions Standard Score | ||||||||||||
End point description |
The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.
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End point type |
Secondary
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End point timeframe |
Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
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Notes [23] - ITT Population [24] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards | ||||||||||||
End point description |
Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14).
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End point type |
Secondary
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End point timeframe |
Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
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Notes [25] - ITT Population [26] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 8.75 Gray Silent Reading Test (GSRT) Reading Quotient | ||||||||||||
End point description |
Gray Silent Reading Test (GSRT)Reading Quotient is a reliable, validated measure of reading comprehension administered in the group setting during the first half hour of the homework session (range: 0,unbounded). A higher score is preferable as it means more questions were answered correctly.
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End point type |
Secondary
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End point timeframe |
Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
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Notes [27] - ITT Population [28] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) Standard Score | ||||||||||||
End point description |
The THS-R (range: unbounded) is a standardized, untimed assessment designed to evaluate neurosensory integration manifested in manuscript and cursive writing. The test includes subtests: writing from memory or dictation the letters of the alphabet in order, single digit-numbers out of order, selected words, and copying selected letters, words, and sentences. Each subtest was scored from zero (poorly formed letters) to 3 (perfectly formed letters). 100 is the normal mean; scores lower than 100 indicate performance worse than normal, scores above 100 indicate performance better than normal.
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End point type |
Secondary
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End point timeframe |
Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period
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Notes [29] - ITT Population [30] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS) | ||||||||||||
End point description |
The DIBELS (range: 0, 376), used to assess reading fluency, consists of standardized, individually administered measures of early literacy development. These short (1 minute) fluency measures were developed based upon essential early literacy domains to assess development of phonological awareness, alphabetic understanding, and automaticity and fluency. Only the paragraph fluency component of an age/grade-appropriate DIBELS was used. A higher score indicated better performance, as it represented that the subject orally read a greater number of words correctly within the time allowed.
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End point type |
Secondary
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End point timeframe |
Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period
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Notes [31] - ITT Population [32] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards | ||||||||||||
End point description |
Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14).
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End point type |
Secondary
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End point timeframe |
Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
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Notes [33] - ITT Population [34] - ITT population |
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No statistical analyses for this end point |
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End point title |
Hour 5.5 Test of Variables of Attention (TOVA) Omissions Standard Score | ||||||||||||
End point description |
The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.
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End point type |
Secondary
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End point timeframe |
Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
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Notes [35] - ITT population [36] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 3.0 Grammar Task | ||||||||||||
End point description |
This task, presented once during a laboratory school day, was designed to index “attention to detail” by determining how many grammatical mistakes each child could identify and circle in a brief paragraph. The errors were not difficult to identify and were designed to show attention to task, not comprehension. A higher number of errors identified, of those possible, was indicative of better attention - identification of grammatical errors(range: 0, 1 represents correct responses divided by the number of possible responses).
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End point type |
Secondary
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End point timeframe |
Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period
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Notes [37] - ITT Population [38] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 8.75 Packet Activity Short Story With Questions for Comprehension | ||||||||||||
End point description |
Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).
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End point type |
Secondary
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End point timeframe |
Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
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Notes [39] - ITT Population [40] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 8.75 Packet Activity Identify Root Word | ||||||||||||
End point description |
Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).
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End point type |
Secondary
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||||||||||||
End point timeframe |
Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
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Notes [41] - ITT Population [42] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 8.75 Packet Activity Alphabetize List of Words | ||||||||||||
End point description |
Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).
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End point type |
Secondary
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||||||||||||
End point timeframe |
Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
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|
|||||||||||||
Notes [43] - ITT Population [44] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 8.75 Packet Activity Identify Multiple Meanings for Words | ||||||||||||
End point description |
Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
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|
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Notes [45] - ITT Population [46] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 8.75 Packet Activity Complete Sentences Using Words Provided | ||||||||||||
End point description |
Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).
|
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End point type |
Secondary
|
||||||||||||
End point timeframe |
Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
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|
|||||||||||||
Notes [47] - ITT Population [48] - ITT Population |
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No statistical analyses for this end point |
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|||||||||||||
End point title |
Hour 8.75 Packet Activity Word Search | ||||||||||||
End point description |
Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses)
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
|
||||||||||||
|
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Notes [49] - ITT Population [50] - ITT Population |
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No statistical analyses for this end point |
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End point title |
Hour 8.75 Packet Activity Decode the Mystery Sentence | ||||||||||||
End point description |
Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
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|
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Notes [51] - ITT Population [52] - ITT Population |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Day 1 to End of treatment
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
11.1
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Reporting groups
|
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Reporting group title |
Concerta (Open-Label Dose Adjustment Period)
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Reporting group description |
Subjects initiated with Concerta as 18 milligram/day (mg/day) once daily. Concerta dose was continuously increased until an optimal individualized dose was achieved, up to a maximum dose of 54 mg/day. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo/Concerta
|
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Reporting group description |
Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54 mg tablet) once daily at lab school day 2 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Concerta/Placebo
|
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Reporting group description |
Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 2% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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28 Oct 2008 |
The first protocol amendment included removal of single-centre text and clarification that subscale scores could be considered to 1) allow subjects with 1 subtype of ADHD (attention deficit hyperactivity disorder) predominating and 2) be used in dose adjustments. Inclusion criteria#4 was updated and visit1 and visit 2 were included. Exclusion criteria #5 changed score to 3, clarified text. Dosage and administration was updated and subscales were allowed for dose adjustments. |
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11 Dec 2008 |
The second protocol amendment included clarification about optimal dose as both total and subscale scores ≤ 75th percentile, Laboratory assessment days shortened to 1 month (28 days) from 6 weeks, In inclusion criteria #2 name of Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K- SADS PL) was corrected |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |