| Primary | Change From Baseline in Digit Span Test Total Score at Week 12 | 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. | 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. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| Baseline | | | Title | Measurements |
|---|
| - OG00011.7± 2.25
- OG00113.7± 2.43
|
| | Change at Week 12 | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| P-value was calculated to compare the data at Baseline and change at Week 12 for the OROS-MPH group | Signed Rank Sum Test | | 0.0387 | | | | | | | | | | | | | No | Superiority or Other | | |
|
| Primary | Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1 | 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. | 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. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Primary | Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2 | 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. | 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. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Primary | Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3 | 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. | 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. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Primary | Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7 | 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. | 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. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 7 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Primary | Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12 | 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. | 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. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale. | 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 | 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. | Posted | | Number | | Percentage of Participants | | End of Week 1, 2, 3, 7 and 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Stroop Color Word Naming Test | 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. | 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. | Posted | | Mean | Standard Deviation | Seconds | | Baseline and End of Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | Wisconsin Card Sorting Test (WCST): Administered Responses (Ra) of Completed Examination | 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. | 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. | Posted | | Mean | Standard Deviation | Responses | | Baseline and End of Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | WCST: Completed Categories (Cc) | 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. | 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. | Posted | | Mean | Standard Deviation | Nunber of Categories Completed | | Baseline and End of Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | WCST: Correct Responses (Rc) | 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. | 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. | Posted | | Mean | Standard Deviation | number of correct responses | | Baseline and End of Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | WCST: Error Responses (Re) | 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. | 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. | Posted | | Mean | Standard Deviation | number of error responses | | Baseline and End of Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | WCST: Percentage of Correct Responses (Rc%) | 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. | 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. | Posted | | Mean | Standard Deviation | Percentage of correct responses | | Baseline and End of Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | WCST: First Response (Rf) | 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. | 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. | Posted | | Mean | Standard Deviation | number of first responses | | Baseline and End of Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | WCST: Percentage of Conceptual Level Responses (Rf%) | 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. | 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. | Posted | | Mean | Standard Deviation | percentage of conceptual level responses | | Baseline and End of Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | WCST: Perseverative Responses (Rp) | 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. | 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. | Posted | | Mean | Standard Deviation | number of perseverative responses | | Baseline and End of Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | WCST: Perseverative Error Responses (Rpe) | 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. | 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. | Posted | | Mean | Standard Deviation | number of perseverative error responses | | Baseline and End of Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | WCST: Percentage of Perseverative Error Responses (Rpe%) | 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. | 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. | Posted | | Mean | Standard Deviation | Percentage of pvt error responses | | Baseline and End of Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | WCST: Non-Persistent Error Responses (nRpe) | 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). | 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. | Posted | | Mean | Standard Deviation | number of non-persistent error responses | | Baseline and End of Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | WCST: Failure to Maintain Set (Fm) | 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). | 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. | Posted | | Mean | Standard Deviation | number of times | | Baseline and End of Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | WCST: Learning to Learn (L-C) | 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). | 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. | Posted | | Mean | Standard Deviation | number of responses | | Baseline and End of Week 12 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Coding Test | 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. | 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. | Posted | | Mean | Standard Deviation | Number of symbols correctly replaced | | Baseline and End of Week 12 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Academic Achievement | 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. | 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. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and End of Week 12 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants With Clinical Global Impression - CGI Scale Score | 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. | 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 | Posted | | Number | | Participants | | End of Week 1, 2, 3, 7 and 12 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Normal | 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. |
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| Secondary | Change From Baseline in I/O Score of IOWA Conners Behavior Rating Scale at Week 12 | 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. | 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. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and End of Week 12 | | | | ID | Title | Description |
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| OG000 | OROS-MPH Group 18 Milligram (mg) | Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d). | | OG001 | OROS-MPH Group 36 mg | Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d) | | OG002 |
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| Secondary | Change From Baseline in Total Scores of Digit Span Test at 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. | 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. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and End of Week 12 | | | | ID | Title | Description |
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| OG000 | OROS-MPH Group 18 Milligram (mg) | Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d). | | OG001 | OROS-MPH Group 36 mg | Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d) |
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| Secondary | Change From Baseline in Completion Time of Stroop Color-word Test at 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. | 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 and "n" signifies participants who were evaluable at each time point for each specific arm. | Posted | | Mean | Standard Deviation | Seconds | | Baseline and End of Week 12 | | | | ID | Title | Description |
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| OG000 | OROS-MPH Group 18 Milligram (mg) | Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d). | | OG001 |
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| Secondary | Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale at 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. | 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. | Posted | | Number | | Percentage of participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | OROS-MPH Group 18 Milligram (mg) | Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d). | | OG001 | OROS-MPH Group 36 mg | Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d). | | OG002 | OROS-MPH Group 54 mg | Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d). |
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| Secondary | Number of Participants Compliant With Treatment | 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. | 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. | Posted | | Number | | participants | | End of Week 12 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Normal | 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. |
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