Trial Outcomes & Findings for Lab School Day Study for CONCERTA of Older Children With ADHD (NCT NCT00799409)

NCT ID: NCT00799409

Last Updated: 2014-05-09

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 78 participants
• Primary outcome timeframe: Hour 4 of the of the Lab School Day during Double-Blind Assessment Period
• Results posted on: 2014-05-09

Participant Flow

Participant milestones

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo/Concerta Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2	Concerta/Placebo 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
Overall Study STARTED	7	36	35
Overall Study COMPLETED	0	36	35
Overall Study NOT COMPLETED	7	0	0

Reasons for withdrawal

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo/Concerta Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2	Concerta/Placebo 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
Overall Study Withdrawal by Subject	1	0	0
Overall Study Lost to Follow-up	1	0	0
Overall Study Optimal Dose Not Achieved	2	0	0
Overall Study Failure to follow study protocol)	1	0	0
Overall Study Did not attend lab school day 1	1	0	0
Overall Study medication compliance	1	0	0

Baseline Characteristics

Lab School Day Study for CONCERTA of Older Children With ADHD

Baseline characteristics by cohort

Measure	Not Randomized n=7 Participants Children who started dose adjustment period, but were not randomized	Placebo/Concerta n=36 Participants Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2	Concerta/Placebo n=35 Participants 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	Total n=78 Participants Total of all reporting groups
Age, Continuous	9.9 years STANDARD_DEVIATION 0.69 • n=5 Participants	10.3 years STANDARD_DEVIATION 1.07 • n=7 Participants	10.0 years STANDARD_DEVIATION 1.14 • n=5 Participants	10.1 years STANDARD_DEVIATION 1.08 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	14 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	22 Participants n=7 Participants	29 Participants n=5 Participants	55 Participants n=4 Participants
Region of Enrollment USA	7 participants n=5 Participants	36 participants n=7 Participants	35 participants n=5 Participants	78 participants n=4 Participants

PRIMARY outcome

Timeframe: Hour 4 of the of the Lab School Day during Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point. 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

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)

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)	—	74.8 Problems attempted Standard Deviation 42.05	103.5 Problems attempted Standard Deviation 38.51

PRIMARY outcome

Timeframe: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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.

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)	—	69.0 Problems correct Standard Deviation 41.02	97.4 Problems correct Standard Deviation 38.99

SECONDARY outcome

Timeframe: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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.

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)	—	9.0 Units on a scale Standard Deviation 6.68	3.1 Units on a scale Standard Deviation 4.10

SECONDARY outcome

Timeframe: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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.

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)	—	11.8 Units on a scale Standard Deviation 6.48	6.7 Units on a scale Standard Deviation 5.03

SECONDARY outcome

Timeframe: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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.

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)	—	20.8 Units on a scale Standard Deviation 11.23	9.9 Units on a scale Standard Deviation 7.44

SECONDARY outcome

Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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).

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 5.5 Test of Variables of Attention (TOVA) ADHD Composite Cutoff Score	—	-4.39 Units on a scale Standard Deviation 3.310	-1.34 Units on a scale Standard Deviation 3.430

SECONDARY outcome

Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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.

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Standard Score	—	73.80 Units on a scale Standard Deviation 23.74	89.72 Units on a scale Standard Deviation 21.320

SECONDARY outcome

Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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.

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Variability Standard Score	—	62.87 Units on a scale Standard Deviation 33.789	85.14 Units on a scale Standard Deviation 34.906

SECONDARY outcome

Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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 in reverse order. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards	—	11.2 Correct Sequences Standard Deviation 4.25	12.2 Correct Sequences Standard Deviation 3.57

SECONDARY outcome

Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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.

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards	—	12.9 Correct Sequences Standard Deviation 3.96	14.3 Correct Sequences Standard Deviation 3.64

SECONDARY outcome

Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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.

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 5.5 Test of Variables of Attention (TOVA) Commissions Standard Score	—	86.42 Units on a scale Standard Deviation 33.261	92.58 Units on a scale Standard Deviation 34.545

SECONDARY outcome

Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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).

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards	—	5.1 Correct Trials Standard Deviation 1.97	5.4 Correct Trials Standard Deviation 2.12

SECONDARY outcome

Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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.

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 8.75 Gray Silent Reading Test (GSRT) Reading Quotient	—	85.9 Units on a scale Standard Deviation 23.60	91.9 Units on a scale Standard Deviation 18.49

SECONDARY outcome

Timeframe: Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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.

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) Standard Score	—	93.6 Units on a scale Standard Deviation 20.77	98.3 Units on a scale Standard Deviation 21.81

SECONDARY outcome

Timeframe: Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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.

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)	—	106.2 Units on a scale Standard Deviation 35.15	112.0 Units on a scale Standard Deviation 35.51

SECONDARY outcome

Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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, 16).

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards	—	9.2 Correct Trials Standard Deviation 1.88	9.3 Correct Trials Standard Deviation 1.70

SECONDARY outcome

Timeframe: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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.

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 5.5 Test of Variables of Attention (TOVA) Omissions Standard Score	—	25.98 Units on a scale Standard Deviation 126.281	64.07 Units on a scale Standard Deviation 88.770

SECONDARY outcome

Timeframe: Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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).

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 3.0 Grammar Task	—	0.241 Units on a scale Standard Deviation 0.1704	0.327 Units on a scale Standard Deviation 0.2204

SECONDARY outcome

Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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).

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 8.75 Packet Activity Short Story With Questions for Comprehension	—	0.609 Units on a scale Standard Deviation 0.2449	0.629 Units on a scale Standard Deviation 0.2843

SECONDARY outcome

Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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).

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 8.75 Packet Activity Identify Root Word	—	0.744 Units on a scale Standard Deviation 0.3058	0.760 Units on a scale Standard Deviation 0.3054

SECONDARY outcome

Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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).

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 8.75 Packet Activity Alphabetize List of Words	—	0.676 Units on a scale Standard Deviation 0.3400	0.676 Units on a scale Standard Deviation 0.3369

SECONDARY outcome

Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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).

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 8.75 Packet Activity Identify Multiple Meanings for Words	—	0.694 Units on a scale Standard Deviation 0.3123	0.795 Units on a scale Standard Deviation 0.3019

SECONDARY outcome

Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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).

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 8.75 Packet Activity Complete Sentences Using Words Provided	—	0.652 Units on a scale Standard Deviation 0.3251	0.741 Units on a scale Standard Deviation 0.3221

SECONDARY outcome

Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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).

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 8.75 Packet Activity Word Search	—	0.935 Units on a scale Standard Deviation 0.1952	0.979 Units on a scale Standard Deviation 0.1123

SECONDARY outcome

Timeframe: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

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).

Outcome measures

Measure	Not Randomized Children who started dose adjustment period, but were not randomized	Placebo n=71 Participants Children randomized to receive Placebo at lab school day 1 or lab school day 2	Concerta n=71 Participants Children randomized to receive Concerta at lab school day 1 or lab school day 2
Hour 8.75 Packet Activity Decode the Mystery Sentence	—	0.960 Units on a scale Standard Deviation 0.1566	0.987 Units on a scale Standard Deviation 0.0501

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Concerta

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Open Label/Non-Lab Day CONCERTA

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=71 participants at risk Placebo was received during the lab school day	Concerta n=71 participants at risk Concerta was received during the lab school day	Open Label/Non-Lab Day CONCERTA n=78 participants at risk Dose adjustment period and double blind period other than lab school day
Metabolism and nutrition disorders Decreased appetite	0.00% 0/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	0.00% 0/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	25.6% 20/78 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).
General disorders Irritability	0.00% 0/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	0.00% 0/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	15.4% 12/78 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).
General disorders Pyrexia	0.00% 0/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	0.00% 0/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	5.1% 4/78 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).
Nervous system disorders Headache	0.00% 0/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	0.00% 0/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	16.7% 13/78 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).
Nervous system disorders Dizziness	0.00% 0/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	0.00% 0/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	5.1% 4/78 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	0.00% 0/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	16.7% 13/78 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).
Psychiatric disorders Initial insomnia	0.00% 0/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	0.00% 0/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	7.7% 6/78 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.4% 1/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	0.00% 0/71 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).	5.1% 4/78 • The sponsor collects adverse events for 14 weeks starting with the signing of the informed consent (up to 4 weeks prior to treatment) continuing until the final visit at early discontinuation or study completion (up to 10 weeks after start of treatment).

Additional Information

VP Medical Affairs, CNS

Ortho-McNeil Janssen Scientific Affairs, LLC

Phone: 609-730-2136

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60