An Efficacy Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention-Deficit/Hyperactivity Disorder (ADHD)

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

Population: ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

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

Population: ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using LOCF.

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

Population: Intent-to-treat (ITT) population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using Last observation carried forward (LOCF).

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

Population: ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

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

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

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

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

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

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

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

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

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

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

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

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

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

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.

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

Population: The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.