OROS Methylphenidate (Concerta) Adolescents Study in Korea

• The changes in Korean ADHD Rating Scale (K-ARS), CGI-S/I evaluated by the investigator and Learning Skill Test (LST) evaluated by the patient [ Time Frame: K-ARS and CGI-S at baseline, day7, 14, 28, 56,and 84; CGI-I at day 56 and 84; LST at baseline and day 84 ] [ Designated as safety issue: No ]
  

• The results of the Audio Digit Span Test [ Time Frame: baseline and day 84 ] [ Designated as safety issue: No ]
  
• The results of Digit Span [ Time Frame: baseline and day 84 ] [ Designated as safety issue: No ]
  
• The results of Finger Widow Test [ Time Frame: baseline and day 84 ] [ Designated as safety issue: No ]
  
• The results of Frontal Lobe - executive function test (COWAT) [ Time Frame: baseline and day 84 ] [ Designated as safety issue: No ]
  
• The results of Stroop test [ Time Frame: baseline and day 84 ] [ Designated as safety issue: No ]
  

This is 12 week, open label (all people involved know the identity of the intervention), prospective, single arm, multicenter study evaluating the effectiveness and tolerability of OROS methylphenidate on learning skill changes for 125 adolescents with Attention Deficit Hyperactivity Disorder (ADHD). As most studies on neuropsychological deficits of ADHD investigated children aged 6 -12, it would be of particular interest to focus the investigation on teenage patients. This study will determine if OROS methylphenidate treatment in adolescent ADHD patients results in positive changes in learning skills and improved neurocognitive functioning. Assessments will be performed at screening, baseline, 6 weeks and 12 weeks. Efficacy evaluations will be performed after 12 weeks or the patient's last visit and will include change from baseline assessment score in Clinical Global Impression of Severity of Illness (CGI-S) scale, Clinical Global Impression of Improvement of illness(CGI-I), ADHD Rating Scale (ARS) and Learning Skill Test (LST) score. During the trial, the following safety and tolerability evaluations will be executed: adverse events evaluation will be completed on each visit and upon early discontinuation, the patient and the parent/guardian will participate in an evaluation before drug administration, blood and urine samples are taken and sent to the laboratory, vital signs will be monitored at every visit, height/weight will be measured and physical exam will be performed at visit 1 and at study end. The patients will be on once daily study medication starting at 18 mg/day in children with less than 30 kg of body weight or at 27 mg/day in children with more than 30 kg. The dose is increased approximately every 7 days in 9 mg or 18 mg increments based on the clinical judgment of the investigator. The need for dose adjustment is assessed at screening, baseline, and after weeks 6 and 12.