Trial Outcomes & Findings for A Long Term Post-Marketing Study on the EffIcacy and Safety of Osmotic Release Oral System (OROS) Methylphenidate on the Cognitive Functions of Attention Deficit Hyperactivity Disorder (ADHD) Participants (NCT NCT01933880)

NCT ID: NCT01933880

Last Updated: 2014-09-17

Results Overview

The digit span test is mainly used to measure the ability of short-term memory and attention. The participant will be given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score is the number of correct responses, where the digits were repeated correctly. One point will be given for each correctly repeated string of digits. The maximum subscore in the Digits Forward is 16, and the maximum subscore in the Digits Backward is 14, summed for a total score of 30. A higher score is indicative of better recall and attention.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

194 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2014-09-17

Participant Flow

Participant milestones

Participant milestones
Measure	OROS-MPH Group Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	Normal Group Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
Overall Study STARTED	153	41
Overall Study COMPLETED	123	40
Overall Study NOT COMPLETED	30	1

Reasons for withdrawal

Reasons for withdrawal
Measure	OROS-MPH Group Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	Normal Group Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
Overall Study Withdrawal by Subject	5	0
Overall Study Lack of Efficacy	1	0
Overall Study Concomitant medication Interference	0	1
Overall Study Followup exceeded 4 days to visit window	19	0
Overall Study Other	4	0
Overall Study Protocol Violation	1	0

Baseline Characteristics

A Long Term Post-Marketing Study on the EffIcacy and Safety of Osmotic Release Oral System (OROS) Methylphenidate on the Cognitive Functions of Attention Deficit Hyperactivity Disorder (ADHD) Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	Total n=168 Participants Total of all reporting groups
Age, Customized Less than 7 to 8 Years	48 participants 1.47 • n=5 Participants	10 participants 1.72 • n=7 Participants	58 participants n=5 Participants
Age, Customized 9 to 10 Years	55 participants n=5 Participants	16 participants n=7 Participants	71 participants n=5 Participants
Age, Customized 11 to 12 Years	25 participants n=5 Participants	14 participants n=7 Participants	39 participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	108 Participants n=5 Participants	23 Participants n=7 Participants	131 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Full Analysis Set (FAS) population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. FAS for normal group included all participants who received baseline assessment scale evaluation and had at least one endpoint assessment scale evaluation.

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Change From Baseline in Digit Span Test Total Score at Week 12 Baseline	13.7 Scores on a scale Standard Deviation 2.43	11.7 Scores on a scale Standard Deviation 2.25	—
Change From Baseline in Digit Span Test Total Score at Week 12 Change at Week 12	0.5 Scores on a scale Standard Deviation 1.48	1 Scores on a scale Standard Deviation 1.5	—

PRIMARY outcome

Timeframe: Baseline and Week 1

Population: FAS population for OROS-MPH Group. Here "N" signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test.

IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.

Outcome measures

Outcome measures
Measure	Normal Group Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=127 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1 Baseline	—	10 Scores on a scale Standard Deviation 2.4	—
Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1 Change at Week 1	—	-2.7 Scores on a scale Standard Deviation 2.18	—

PRIMARY outcome

Timeframe: Baseline and Week 2

Outcome measures

Outcome measures
Measure	Normal Group Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=127 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2 Baseline	—	10 Scores on a scale Standard Deviation 2.4	—
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2 Change at Week 2	—	-4.1 Scores on a scale Standard Deviation 2.73	—

PRIMARY outcome

Timeframe: Baseline and Week 3

Outcome measures

Outcome measures
Measure	Normal Group Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=127 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3 Baseline	—	10 Scores on a scale Standard Deviation 2.4	—
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3 Change at Week 3	—	-5 Scores on a scale Standard Deviation 2.81	—

PRIMARY outcome

Timeframe: Baseline and Week 7

Outcome measures

Outcome measures
Measure	Normal Group Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=127 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7 Baseline	—	10 Scores on a scale Standard Deviation 2.4	—
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7 Change at Week 7	—	-5.8 Scores on a scale Standard Deviation 2.91	—

PRIMARY outcome

Timeframe: Baseline and Week 12

Outcome measures

Outcome measures
Measure	Normal Group Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=127 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12 Baseline	—	10 Scores on a scale Standard Deviation 2.4	—
Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12 Change at Week 12	—	-6.2 Scores on a scale Standard Deviation 3.08	—

SECONDARY outcome

Timeframe: End of Week 1, 2, 3, 7 and 12

Population: FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test.

Remission rate is the percentage of participants with total score of IO sub-scale less than or equal to 5 in IOWA Conners measurement scale

Outcome measures

Outcome measures
Measure	Normal Group Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale. End of Week 7	—	78.74 Percentage of Participants	—
Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale. End of Week 1	—	25.98 Percentage of Participants	—
Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale. End of Week 2	—	51.97 Percentage of Participants	—
Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale. End of Week 3	—	66.93 Percentage of Participants	—
Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale. End of Week 12	—	81.10 Percentage of Participants	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

Population: FAS for OROS-MPH Group included participants who took at least 1 study drug therapy and had at least 1 efficacy evaluation. FAS for normal group included participants who had baseline assessment scale evaluation and had at least 1 endpoint assessment scale evaluation. 'n'=participants who were evaluable at each specific time point for each arm.

This is a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A participant will be given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test is scored on the number of correct answers. There are 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. Median naming time in the Stroop color word naming test will be assessed. Stroop color word naming test 1 ,2 ,3 and 4 stand for gradually increased difficulty and each test has a corresponding baseline and endpoint.

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Stroop Color Word Naming Test Test 2: Baseline (n=128, 40)	7.15 Seconds Standard Deviation 2.6341	19.32 Seconds Standard Deviation 14.8072	—
Stroop Color Word Naming Test Test 4: Baseline (n=128, 40)	11.763 Seconds Standard Deviation 4.4202	22.868 Seconds Standard Deviation 11.3502	—
Stroop Color Word Naming Test Test 1: Baseline (n=128, 40)	6.213 Seconds Standard Deviation 2.3174	20.561 Seconds Standard Deviation 17.5433	—
Stroop Color Word Naming Test Test 1: End of Week 12 (n=111, 40)	5.7 Seconds Standard Deviation 1.8355	18.961 Seconds Standard Deviation 5.4474	—
Stroop Color Word Naming Test Test 2: End of Week 12 (n=111, 40)	6.675 Seconds Standard Deviation 2.2886	18.281 Seconds Standard Deviation 13.6981	—
Stroop Color Word Naming Test Test 3: Baseline (n=128, 40)	6.875 Seconds Standard Deviation 2.6451	18.652 Seconds Standard Deviation 14.5219	—
Stroop Color Word Naming Test Test 3: End of Week 12 (n=111, 40)	6.513 Seconds Standard Deviation 2.3898	16.946 Seconds Standard Deviation 12.1586	—
Stroop Color Word Naming Test Test 4: End of Week 12 (n=111, 40)	10.488 Seconds Standard Deviation 4.2176	19.388 Seconds Standard Deviation 9.8989	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

Population: FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. "n" signifies participants who were evaluable at each time point for each specific arm.

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. During number of trials administered or administered responses, participants were administered 128 cards and asked to sort the cards until all the 6 sorting categories was completed. Response number used to complete all 6 categories ranges from 50 to 128, lesser the better.

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Wisconsin Card Sorting Test (WCST): Administered Responses (Ra) of Completed Examination Baseline (n=128, 40)	120.8 Responses Standard Deviation 5.53	125.1 Responses Standard Deviation 8.74	—
Wisconsin Card Sorting Test (WCST): Administered Responses (Ra) of Completed Examination End of Week 12 (n=111, 40)	117.1 Responses Standard Deviation 17.37	116.4 Responses Standard Deviation 17.68	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. In completed categoriies, number of categories completed out of 6 sorting categories after the test was evaluated. Ranges from 0 to 6. The more the number of categories completed the better is the response.

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
WCST: Completed Categories (Cc) Baseline (n=128, 40)	3.3 Nunber of Categories Completed Standard Deviation 1.68	3.2 Nunber of Categories Completed Standard Deviation 1.56	—
WCST: Completed Categories (Cc) End of Week 12 (n=111, 40)	4 Nunber of Categories Completed Standard Deviation 1.34	4.1 Nunber of Categories Completed Standard Deviation 1.54	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. The number of correct responses which meets all the requirements according to the response principles was evaluated. Ranges from 0-116, the more the better.

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
WCST: Correct Responses (Rc) Baseline (n=128, 40)	77.9 number of correct responses Standard Deviation 12.27	72.9 number of correct responses Standard Deviation 15.65	—
WCST: Correct Responses (Rc) End of Week 12 (n=111, 40)	84.7 number of correct responses Standard Deviation 12.3	80.3 number of correct responses Standard Deviation 12.25	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of error responses which did not comply with the response principles was evaluated. Ranges from 0 to 128, the less the better.

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
WCST: Error Responses (Re) Baseline (n=128, 40)	42.9 number of error responses Standard Deviation 17.77	52.3 number of error responses Standard Deviation 18.59	—
WCST: Error Responses (Re) End of Week 12 (n= 111, 40)	32.3 number of error responses Standard Deviation 15.11	36.1 number of error responses Standard Deviation 16.93	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of correct responses which meets all the requirements according to the response principles was evaluated. Ranges from 0 to 100 percent (%), the more the better.

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
WCST: Percentage of Correct Responses (Rc%) Baseline (n=128, 40)	65.52 Percentage of correct responses Standard Deviation 12.6227	58.678 Percentage of correct responses Standard Deviation 13.8072	—
WCST: Percentage of Correct Responses (Rc%) End of Week 12 (n=111, 40)	73.34 Percentage of correct responses Standard Deviation 10.5072	70.096 Percentage of correct responses Standard Deviation 11.6311	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of responses needed to complete the first color classification was evaluated. Ranges from 9 to 128, the lesser the better.

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
WCST: First Response (Rf) Baseline (n=128,40)	25.2 number of first responses Standard Deviation 24.45	22.6 number of first responses Standard Deviation 22.29	—
WCST: First Response (Rf) End of Week 12 (n=111, 40)	26.5 number of first responses Standard Deviation 22.77	23.4 number of first responses Standard Deviation 19	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of the responses completed with 3-10 continuous correct during the entire measuring process was evaluated. Ranges from 0 to 100%, the more the better.

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
WCST: Percentage of Conceptual Level Responses (Rf%) Baseline (n=128, 40)	54.73 percentage of conceptual level responses Standard Deviation 18.48	46.36 percentage of conceptual level responses Standard Deviation 18.589	—
WCST: Percentage of Conceptual Level Responses (Rf%) End of Week 12 (n=111, 40)	65 percentage of conceptual level responses Standard Deviation 16.036	61.07 percentage of conceptual level responses Standard Deviation 17.244	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of perseverative responses were the responses which applied continuity principle for matching answers was evaluated. Ranges from 0 to 100, the less the better.

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
WCST: Perseverative Responses (Rp) Baseline (n=128, 40)	26.5 number of perseverative responses Standard Deviation 14.09	33.7 number of perseverative responses Standard Deviation 20.47	—
WCST: Perseverative Responses (Rp) End of Week 12 (n=111, 40)	18.6 number of perseverative responses Standard Deviation 12.97	22 number of perseverative responses Standard Deviation 16.21	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Perseverative error responses are the number of responses which applied continuity principle for matching answers and also had the wrong answer was evaluated. Ranges from 0 to 128, the less the better.

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
WCST: Perseverative Error Responses (Rpe) Baseline (n=128, 40)	23 number of perseverative error responses Standard Deviation 11.03	28.7 number of perseverative error responses Standard Deviation 15.24	—
WCST: Perseverative Error Responses (Rpe) End of Week 12 (n=111, 40)	16.4 number of perseverative error responses Standard Deviation 9.85	19.4 number of perseverative error responses Standard Deviation 12.54	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative (pvt) errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of persistent errors out of total number of responses was evaluated. Ranges from 0 to 100%, the less the better.

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
WCST: Percentage of Perseverative Error Responses (Rpe%) End of Week 12 (n=111, 40)	13.59 Percentage of pvt error responses Standard Deviation 7.167	16.07 Percentage of pvt error responses Standard Deviation 9.188	—
WCST: Percentage of Perseverative Error Responses (Rpe%) Baseline (n=128, 40)	18.45 Percentage of pvt error responses Standard Deviation 8.083	22.67 Percentage of pvt error responses Standard Deviation 11.658	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Non perseverative error responses are the errors remaining after subtracting persistent errors from total errors. Ranges from 0 to 128 and was not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case).

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
WCST: Non-Persistent Error Responses (nRpe) End of Week 12 (n=111, 40)	15.8 number of non-persistent error responses Standard Deviation 7.737	16.75 number of non-persistent error responses Standard Deviation 9.241	—
WCST: Non-Persistent Error Responses (nRpe) Baseline (n=128, 40)	19.98 number of non-persistent error responses Standard Deviation 8.94	23.54 number of non-persistent error responses Standard Deviation 11.606	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. The frequency (number of times) of responses completed with 5 to 9 continuous correct was evaluated. Ranges from 0 to 26 and was not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case).

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
WCST: Failure to Maintain Set (Fm) Baseline (n=128, 40)	2.3 number of times Standard Deviation 1.65	1.7 number of times Standard Deviation 1.62	—
WCST: Failure to Maintain Set (Fm) End of Week 12 (n=111, 40)	2.5 number of times Standard Deviation 1.75	2 number of times Standard Deviation 1.78	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. "Learning to learn" indicator was a measure of decrement in the number of responses needed to achieve each successive category. The raw score ranged from 0 to 100. The high, negative value suggests the participants could not effectively learn the task presented by the WCST. Only calculated in those completed 3 or more categories and not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case).

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
WCST: Learning to Learn (L-C) Baseline (n=128, 40)	-2.37 number of responses Standard Deviation 6.31	-2.49 number of responses Standard Deviation 6.451	—
WCST: Learning to Learn (L-C) End of Week 12 (n=111, 40)	-1.34 number of responses Standard Deviation 4.391	-1.87 number of responses Standard Deviation 3.85	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

The coding Test is a common test indicator for perceptual speed. The test presents a series of corresponding relationship between graphics and symbols to the participant, and then participants will be required to fill out the appropriate symbol following single symbol in the test part. The test is limited within 150 seconds and evaluated the number of symbols been replaced correctly by the participants.

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Coding Test Baseline (n=128, 40)	77.4 Number of symbols correctly replaced Standard Deviation 44.83	63.4 Number of symbols correctly replaced Standard Deviation 40.14	—
Coding Test End of Week 12 (n=111, 40)	83.1 Number of symbols correctly replaced Standard Deviation 44.19	73.2 Number of symbols correctly replaced Standard Deviation 41.41	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

Mathematics and language scores will be obtained from their corresponding examinations at school. Scores ranges from 0-100 respectively. Mathematics and language would be summarized separately.

Outcome measures

Outcome measures
Measure	Normal Group n=40 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Academic Achievement MA: End of Week 12 (n=111, 40)	96.13 scores on a scale Standard Deviation 3.625	86.05 scores on a scale Standard Deviation 11.579	—
Academic Achievement Chinese Achievement: Basline (n=128, 40)	94.21 scores on a scale Standard Deviation 4.301	77.35 scores on a scale Standard Deviation 13.791	—
Academic Achievement Chinese Achievement: End of Week 12(n=111, 40)	94.56 scores on a scale Standard Deviation 4.396	83.94 scores on a scale Standard Deviation 10.737	—
Academic Achievement Mathematical Achievement (MA):Baseline (n=128, 40)	96.23 scores on a scale Standard Deviation 3.641	78.86 scores on a scale Standard Deviation 15.407	—

SECONDARY outcome

Timeframe: End of Week 1, 2, 3, 7 and 12

CGI is an overall rating scale. Clinical Global Impression (Improvement of Diseases) is divided into seven grades: 1=very significant improvement, 24=significant improvement or advanced, 3=improvement or slightly advanced, 4=no change, 5=slight aggravation, 6=significant aggravation, and 7=very significant aggravation or seriously aggravated. Number of participants in each category of grade were assessed.

Outcome measures

Outcome measures
Measure	Normal Group Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=128 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Number of Participants With Clinical Global Impression - CGI Scale Score Significantly Advanced: End of Week 1	—	20 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Significantly Advanced: End of Week 2	—	28 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Significantly Advanced: End of Week 3	—	29 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score No Change: End of Week 12	—	3 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Slightly Aggravated: End of Week 3	—	0 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Slightly Aggravated: End of Week 12	—	1 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Aggravated: End of Week 7	—	0 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Seriously Aggravated: End of Week 3	—	0 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Seriously Aggravated: End of Week 7	—	0 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Seriously Aggravated: End of Week 12	—	0 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Significantly Advanced: End of Week 7	—	35 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Significantly Advanced: End of Week 12	—	36 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Advanced: End of Week 1	—	59 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Advanced: End of Week 2	—	53 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Advanced: End of Week 3	—	44 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Advanced: End of Week 7	—	41 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Advanced: End of Week 12	—	46 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Slightly Advanced: End of Week 1	—	33 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Slightly Advanced: End of Week 2	—	28 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Slightly Advanced: End of Week 3	—	33 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Slightly Advanced: End of Week 7	—	28 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Slightly Advanced: End of Week 12	—	25 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score No Change: End of Week 1	—	15 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score No Change: End of Week 2	—	10 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score No Change: End of Week 3	—	11 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score No Change: End of Week 7	—	7 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Slightly Aggravated: End of Week 1	—	0 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Slightly Aggravated: End of Week 2	—	2 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Slightly Aggravated: End of Week 7	—	3 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Aggravated: End of Week 1	—	0 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Aggravated: End of Week 2	—	0 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Aggravated: End of Week 3	—	0 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Aggravated: End of Week 12	—	0 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Seriously Aggravated: End of Week 1	—	0 Participants	—
Number of Participants With Clinical Global Impression - CGI Scale Score Seriously Aggravated: End of Week 2	—	0 Participants	—

SECONDARY outcome

Timeframe: Baseline and End of Week 12

Population: FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here "N" signifies participants who were evaluable for this outcome measure.

IOWA conners behavior rating scale score in different dosage groups will be accessed to evaluate relationship between therapeutic effect and dosage. IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.

Outcome measures

Outcome measures
Measure	Normal Group n=30 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=86 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg n=1 Participants Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Change From Baseline in I/O Score of IOWA Conners Behavior Rating Scale at Week 12 Baseline	10.3 Scores on a scale Standard Deviation 2.39	10 Scores on a scale Standard Deviation 2.42	7 Scores on a scale Standard Deviation 0
Change From Baseline in I/O Score of IOWA Conners Behavior Rating Scale at Week 12 Change at End of Week 12	-5.8 Scores on a scale Standard Deviation 3.32	-6.8 Scores on a scale Standard Deviation 2.82	-4 Scores on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline and End of Week 12

The digit span test total score will be accessed in different dosage groups to evaluate the relationship between therapeutic effect and dosage. The digit span test is mainly used to measure the ability of short-term memory and attention. The participant will be given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score is the number of correct responses, where the digits were repeated correctly. One point will be given for each correctly repeated string of digits. The maximum subscore in the Digits Forward is16, and the maximum subscore in the Digits Backward is 14, for a total score of 30. A higher score was indicative of better recall and attention.

Outcome measures

Outcome measures
Measure	Normal Group n=30 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=86 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg n=1 Participants Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Change From Baseline in Total Scores of Digit Span Test at Week 12 Baseline	11.3 Scores on a scale Standard Deviation 1.95	11.7 Scores on a scale Standard Deviation 2.4	15 Scores on a scale Standard Deviation 0
Change From Baseline in Total Scores of Digit Span Test at Week 12 Change at End of Week 12	0.8 Scores on a scale Standard Deviation 1.56	1.2 Scores on a scale Standard Deviation 1.54	0 Scores on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline and End of Week 12

Completion time of stroop color-word test in different dosage groups will be accessed to evaluate the relationship between therapeutic effect and dosage. This is a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A participant will be given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test will be scored on the number of correct answers. There are 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. Median time of the naming time in the Stroop color word naming test will be accessed. Stroop color word naming test 1 ,2 ,3 and 4 stand for gradually increased difficulty and each test has a corresponding baseline and endpoint.

Outcome measures

Outcome measures
Measure	Normal Group n=30 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=86 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg n=1 Participants Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Change From Baseline in Completion Time of Stroop Color-word Test at Week 12 Test 1: Baseline (n=86, 30, 1)	17.7 Seconds Standard Deviation 13.654	22.229 Seconds Standard Deviation 18.7304	5 Seconds Standard Deviation 0
Change From Baseline in Completion Time of Stroop Color-word Test at Week 12 Test 1: Change at End of Week 12 (n=82, 27, 1)	-1 Seconds Standard Deviation 4.308	-3.318 Seconds Standard Deviation 5.6413	0 Seconds Standard Deviation 0
Change From Baseline in Completion Time of Stroop Color-word Test at Week 12 Test 2: Baseline (n=86, 30, 1)	17.29 Seconds Standard Deviation 11.7025	20.538 Seconds Standard Deviation 15.3567	9 Seconds Standard Deviation 0
Change From Baseline in Completion Time of Stroop Color-word Test at Week 12 Test 2: Change at End of Week 12 (n=82, 27, 1)	-1.233 Seconds Standard Deviation 3.9809	-2.164 Seconds Standard Deviation 5.2669	0 Seconds Standard Deviation 0
Change From Baseline in Completion Time of Stroop Color-word Test at Week 12 Test 3: Baseline (n=86, 30, 1)	17.473 Seconds Standard Deviation 14.2673	19.515 Seconds Standard Deviation 14.6203	7 Seconds Standard Deviation 0
Change From Baseline in Completion Time of Stroop Color-word Test at Week 12 Test 3: Change at End of Week 12 (n=82, 27, 1)	-2.996 Seconds Standard Deviation 6.6313	-2.336 Seconds Standard Deviation 5.3987	3 Seconds Standard Deviation 0
Change From Baseline in Completion Time of Stroop Color-word Test at Week 12 Test 4: Baseline (n=86, 30, 1)	22.154 Seconds Standard Deviation 9.2451	23.61 Seconds Standard Deviation 12.135	15 Seconds Standard Deviation 0
Change From Baseline in Completion Time of Stroop Color-word Test at Week 12 Test 4: Change at End of Week 12 (n=82, 27, 1)	-3.974 Seconds Standard Deviation 6.0143	-4.374 Seconds Standard Deviation 7.5921	1 Seconds Standard Deviation 0

SECONDARY outcome

Timeframe: Week 12

Remission rate in different dosage groups will be accessed to evaluate the relationship between therapeutic effect and dosage. Remission rate is the percentage of participants with total score of IO sub-scale less than or equal to 5 in IOWA Conners measurement scale.

Outcome measures

Outcome measures
Measure	Normal Group n=30 Participants Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=86 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg n=1 Participants Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale at Week 12	74.07 Percentage of participants	85.37 Percentage of participants	100.00 Percentage of participants

SECONDARY outcome

Timeframe: End of Week 12

Population: FAS population for OROS-MPH Group. Here "N" signifies participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test.

Number of Participants who are Compliant with Treatment will be accessed. Less than 80 percent and more than 120 percent compliance signifies bad compliance, 80 to 120 percent compliance signifies good compliance . The compliance was calculated by the percentage of dose (actual dose multiplied by 100/theoretical dose).The theoretical dose means the dose prescribed by the Investigator.

Outcome measures

Outcome measures
Measure	Normal Group Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.	OROS-MPH Group n=127 Participants Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.	OROS-MPH Group 54 mg Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
Number of Participants Compliant With Treatment More than 120 percent	—	0 participants	—
Number of Participants Compliant With Treatment Less than 80 percent	—	17 participants	—
Number of Participants Compliant With Treatment Between 80 to 120 percent	—	110 participants	—

Adverse Events

OROS-MPH Group

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	OROS-MPH Group n=149 participants at risk Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	0.67% 1/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Gastrointestinal disorders Nausea	1.3% 2/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.67% 1/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Respiratory, thoracic and mediastinal disorders Cough	0.67% 1/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Respiratory, thoracic and mediastinal disorders Mouth and Pharynx Pain	0.67% 1/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Infection	2.0% 3/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Psychiatric disorders Difficulty in falling asleep	0.67% 1/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Psychiatric disorders Insomnia	2.0% 3/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Psychiatric disorders Irritability	0.67% 1/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
General disorders Fever	0.67% 1/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Metabolism and nutrition disorders Loss of Appetite	12.8% 19/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Ear and labyrinth disorders Tinnitus	0.67% 1/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Infections and infestations Tonsillitis	0.67% 1/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Investigations Abnormal Heart Rate	0.67% 1/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Investigations Decreased Blood Pressure	1.3% 2/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Nervous system disorders Low sleep quality	2.0% 3/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Nervous system disorders Headache	1.3% 2/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Nervous system disorders Dizziness	1.3% 2/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.
Nervous system disorders Difficulty in falling asleep	0.67% 1/149 Safety Set for OROS-MPH Group included all participants who received at least one study drug therapy and at least one safety evaluation. Adverse events was not evaluated for normal group as participants did not receive any study drug in this group. Participants were only assessed for changes in the cognitive functions.

Additional Information

Director - CNS & Pain, CDMA, China R&D and SA

Xi'an Janssen Pharmaceutical Ltd.

Phone: +86 10 5821-8307

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days .In the event that issues arise regarding scientific integrity, the sponsor will review these issues with the investigator.
Publication restrictions are in place

Restriction type: OTHER