A Phase 4 interventional study of OROS Methylphenidate HCl in Attention Deficit Disorder With Hyperactivity, sponsored by Janssen Korea, Ltd., Korea. Completed. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2013-08-23.
Sponsored by Janssen Korea, Ltd., Korea · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy, tolerability and effects of Osmotic Release Oral System (OROS) methylphenidate hydrochloride (HCl) on learning skill changes in Korean participants with Attention-Deficit Hyperactivity Disorder (ADHD).
This is 12 week, open label (all people involved know the identity of the intervention), prospective (study following participants forward in time), single arm, multicenter study (when more than one hospital or medical school team work on a medical research study) of OROS methylphenidate HCl. The study will consist of 6 visits at Screening, Baseline, Week 1, 3, 6 and 12. The participants already on other ADHD medications in addition to methylphenidate will be required to undergo a washout period (period when receiving no treatment) of at least 1 week. The participants will be on once daily study medication starting at 18 milligram per day (mg/day) in participants with less than 30 kilogram (kg) of body weight or at 27 mg/day in participants with more than 30 kg. The dose will be increased by 9 mg or 18 mg every week for up to Week 6 based on the treatment efficacy and tolerability, followed by a maximum maintenance dose of 72 mg orally once daily up to Week 12, during which the dose can be decreased by 9 mg depending on tolerability. Efficacy will primarily be assessed using Clinical Global Impression of Severity of Illness (CGI-S) scale, Clinical Global Impression of Improvement of Illness (CGI-I) scale, Korean version of ADHD-IV Rating Scale (K-ARS) and Learning Skill Test (LST) score. Participants' safety will be monitored.
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Drug: OROS Methylphenidate HCl
Osmotic Release Oral System (OROS) Methylphenidate HCl tablet will be given orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) of body weight and 27 mg for those more than or equal to 30 kg; the dose can be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg will be given orally once daily up to Week 12.
Also known as: Concerta
Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score
The K-ARS is a rating scale that is used for the ADHD diagnosis and the assessment of treatment efficacy and comprises 18 items in total on the basis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), each item being rated from 0-3 points. The total score ranges from 0-54 with 0=normal and 54=severe condition.
Time frame: Week 12
Clinical Global Impression - Severity (CGI-S) Score
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
Time frame: Week 12
Clinical Global Impression - Improvement (CGI-I) Score
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time frame: Week 12
Learning Skill Test (LST) Total Score
The LST measures learning ability of student. This scale is composed of 7 sections: self control, participation, task accomplishment, reading, writing, test taking and information processing. It consists of 70 items for middle school student (age 13-15 years) and 80 items for high school student (age 16-18 years). Each item is rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The total score range is 70-350 for middle school version and 80-400 for high school version where higher score indicates better ability for learning. In result analysis, each sub-score and total score was converted to T-score for normalization. The score range of T-score is from 1 to 100 with a mean of 50. Higher score indicates better ability for learning.
Time frame: Week 12
Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors
The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/commission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The total value for both, omission errors and commission errors, ranges from 0-100 errors where high value indicates worsening attention.
Time frame: Baseline and Week 12
Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability
The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/comission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The score range for both, reaction time and response variability, is 0-100. High score indicates worsening attention. If one or over factor's score is over 65 point, the participant is resulted in having attention deficit.
Time frame: Baseline and Week 12
Digit Span Test Score
Each participant individually was given a sequence of numbers, with the sequence becoming progressively longer, to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. 1 point was awarded if the participant passed only 1 trial of a sequence length. 0 points were given if the participant failed both trials. Total score range was 0-16 (forwards) and 0-14 (backwards). A higher score was indicative of better recall and attention.
Time frame: Baseline and Week 12
Finger Window (FW) Test Score
In FW test, a participant shows memory of a demonstrated visual pattern using a 8x11 inch plastic template containing 9 asymmetrically located holes. The examiner models a given sequence of holes and asks the participant to imitate the sequence by placing his/her finger through the same holes in the correct order. The total number of correct sequences constitutes the total score which ranges from 0-24 (forward FW) and 0-28 (backward FW) with higher score indicating a more favorable health state.
Time frame: Baseline and Week 12
Controlled Oral Words Association Test (COWAT) Score
This test measures the executive function of the frontal lobe and is consisted of examinations of category/meaning fluency and letter/phoneme fluency. It consisted of three 60 second word generation trials in which the participant orally generates as many words as possible that begin with target letters F, A and S. Dependent variables included total number of acceptable words generated for each target letter and total number of words generated across all three letter trials. Total score was calculated as sum of acceptable words generated, with higher scores indicating better verbal fluency.
Time frame: Baseline and Week 12
Stroop Test Result for Reaction Time
This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. This test estimates spending time for execution. High spending time indicates low ability of suppression of automation.
Time frame: Baseline and Week 12
Stroop Test Result for False Reaction
This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. The total value ranges from 0-24 errors for each execution where high value indicates worsening attention.
Time frame: Baseline and Week 12
Stroop Test Score for Ratio Interference
Ratio interference is calculated by dividing simple execution time by interfering execution time. The score range is 0-1. Higher value indicates better ability of suppression of automation.
Time frame: Baseline and Week 12
| Milestone | OROS Methylphenidate HCl |
|---|---|
| Started | 115 |
| Treated | 113 |
| Completed | 92 |
| Not completed | 23 |
| Withdrew: Adverse event | 6 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Protocol violation | 6 |
| Withdrew: Withdrawal by subject | 8 |
| Withdrew: Enrolled, but not treated | 2 |
The K-ARS is a rating scale that is used for the ADHD diagnosis and the assessment of treatment efficacy and comprises 18 items in total on the basis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), each item being rated from 0-3 points. The total score ranges from 0-54 with 0=normal and 54=severe condition.
| Units on a scale | OROS Methylphenidate HCl |
|---|---|
| Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score | 11.78 ± 7.64 |
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
| Units on a scale | OROS Methylphenidate HCl |
|---|---|
| Clinical Global Impression - Severity (CGI-S) Score | 2.81 ± 1.12 |
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
| Units on a scale | OROS Methylphenidate HCl |
|---|---|
| Clinical Global Impression - Improvement (CGI-I) Score | 2.14 ± 0.75 |
The LST measures learning ability of student. This scale is composed of 7 sections: self control, participation, task accomplishment, reading, writing, test taking and information processing. It consists of 70 items for middle school student (age 13-15 years) and 80 items for high school student (age 16-18 years). Each item is rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The total score range is 70-350 for middle school version and 80-400 for high school version where higher score indicates better ability for learning. In result analysis, each sub-score and total score was converted to T-score for normalization. The score range of T-score is from 1 to 100 with a mean of 50. Higher score indicates better ability for learning.
| T-score | OROS Methylphenidate HCl |
|---|---|
| Learning Skill Test (LST) Total Score | 49.61 ± 11.57 |
The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/commission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The total value for both, omission errors and commission errors, ranges from 0-100 errors where high value indicates worsening attention.
| Errors | OROS Methylphenidate HCl |
|---|---|
| Omission errors: Baseline | 58.88 ± 27.35 |
| Omission errors: Week 12 | 57.40 ± 48.79 |
| Commission errors: Baseline | 62.98 ± 32.32 |
| Commission errors: Week 12 | 51.70 ± 21.19 |
The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/comission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The score range for both, reaction time and response variability, is 0-100. High score indicates worsening attention. If one or over factor's score is over 65 point, the participant is resulted in having attention deficit.
| Units on scale | OROS Methylphenidate HCl |
|---|---|
| Reaction time average: Baseline | 54.32 ± 15.45 |
| Reaction time average: Week 12 | 49.73 ± 26.33 |
| Response variability: Baseline | 85.77 ± 60.21 |
| Response variability: Week 12 | 59.42 ± 64.77 |
Each participant individually was given a sequence of numbers, with the sequence becoming progressively longer, to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. 1 point was awarded if the participant passed only 1 trial of a sequence length. 0 points were given if the participant failed both trials. Total score range was 0-16 (forwards) and 0-14 (backwards). A higher score was indicative of better recall and attention.
| Units on a scale | OROS Methylphenidate HCl |
|---|---|
| Forward: Baseline | 11.19 ± 2.92 |
| Forward: Week 12 | 11.56 ± 2.90 |
| Backward: Baseline | 7.09 ± 2.39 |
| Backward: Week 12 | 7.32 ± 2.41 |
In FW test, a participant shows memory of a demonstrated visual pattern using a 8x11 inch plastic template containing 9 asymmetrically located holes. The examiner models a given sequence of holes and asks the participant to imitate the sequence by placing his/her finger through the same holes in the correct order. The total number of correct sequences constitutes the total score which ranges from 0-24 (forward FW) and 0-28 (backward FW) with higher score indicating a more favorable health state.
| Units on a scale | OROS Methylphenidate HCl |
|---|---|
| Forward FW: Baseline | 18.42 ± 4.60 |
| Forward FW: Week 12 | 19.09 ± 4.49 |
| Backward FW: Baseline | 15.59 ± 4.97 |
| Backward FW: Week 12 | 17.36 ± 3.84 |
This test measures the executive function of the frontal lobe and is consisted of examinations of category/meaning fluency and letter/phoneme fluency. It consisted of three 60 second word generation trials in which the participant orally generates as many words as possible that begin with target letters F, A and S. Dependent variables included total number of acceptable words generated for each target letter and total number of words generated across all three letter trials. Total score was calculated as sum of acceptable words generated, with higher scores indicating better verbal fluency.
| Words | OROS Methylphenidate HCl |
|---|---|
| Category/semantic: Baseline | 29.71 ± 5.86 |
| Category/semantic: Week 12 | 30.62 ± 6.16 |
| Letter/phenomic: Baseline | 28.71 ± 10.82 |
| Letter/phenomic: Week 12 | 33.78 ± 11.18 |
This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. This test estimates spending time for execution. High spending time indicates low ability of suppression of automation.
| Seconds | OROS Methylphenidate HCl |
|---|---|
| Simple execution time: Baseline | 14.78 ± 3.8 |
| Simple execution time: Week 12 | 13.64 ± 3.27 |
| Middle execution time: Baseline | 15.88 ± 3.56 |
| Middle execution time: Week 12 | 15.04 ± 4.57 |
| Interfering execution time: Baseline | 22.12 ± 6.18 |
| Interfering execution time: Week 12 | 19.72 ± 5.63 |
This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. The total value ranges from 0-24 errors for each execution where high value indicates worsening attention.
| Errors | OROS Methylphenidate HCl |
|---|---|
| Simple execution false reaction: Baseline | 0.4 ± 0.77 |
| Simple execution false reaction: Week 12 | 0.16 ± 0.39 |
| Middle execution false reaction: Baseline | 0.3 ± 0.67 |
| Middle execution false reaction: Week 12 | 0.2 ± 0.47 |
| Interfering execution false reaction: Baseline | 1.04 ± 1.29 |
| Interfering execution false reaction: Week 12 | 0.84 ± 1.00 |
Ratio interference is calculated by dividing simple execution time by interfering execution time. The score range is 0-1. Higher value indicates better ability of suppression of automation.
| Units on a scale | OROS Methylphenidate HCl |
|---|---|
| Baseline | 0.70 ± 0.19 |
| Week 12 | 0.72 ± 0.19 |
Collected over After signing of informed consent up to Week 12. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OROS Methylphenidate HCl | — | 2/113 (1.8%) | 98/113 (86.7%) |
| Event | OROS Methylphenidate HCl |
|---|---|
| LymphadenitisBlood and lymphatic system disorders | 1/113 |
| AppendicitisInfections and infestations | 1/113 |
| Event | OROS Methylphenidate HCl |
|---|---|
| Decreased appetiteMetabolism and nutrition disorders | 66/113 |
| InsomniaPsychiatric disorders | 37/113 |
| NauseaGastrointestinal disorders | 32/113 |
| HeadacheNervous system disorders | 31/113 |
| Abdominal pain upperGastrointestinal disorders | 19/113 |
| NasopharyngitisInfections and infestations | 19/113 |
| IrritabilityGeneral disorders | 16/113 |
| Stomach discomfortGastrointestinal disorders | 15/113 |
| FatigueGeneral disorders | 13/113 |
| DizzinessNervous system disorders | 11/113 |
| Age Continuous(Years) | OROS Methylphenidate HCl |
|---|---|
| Mean | 15.24 ± 1.43 |
| Sex: Female, Male(Participants) | OROS Methylphenidate HCl |
|---|---|
| Female | 27 |
| Male | 86 |
| Korean Version of Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score(Units on a scale) | OROS Methylphenidate HCl |
|---|---|
| Mean | 27.58 ± 8.92 |
| Clinical Global Impression - Severity (CGI-S) Score(Units on a scale) | OROS Methylphenidate HCl |
|---|---|
| Mean | 4.88 ± 0.79 |
| Learning Skill Test (LST) Total Score(T-score) | OROS Methylphenidate HCl |
|---|---|
| Mean | 40.97 ± 11.07 |
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Janssen Korea, Ltd., Korea