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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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
Janssen Korea, Ltd., Korea
Published on BioPortfolio: 2014-08-27T03:16:15-0400
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A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.
A behavior disorder originating in childhood in which the essential features are signs of developmentally inappropriate inattention, impulsivity, and hyperactivity. Although most individuals have symptoms of both inattention and hyperactivity-impulsivity, one or the other pattern may be predominant. The disorder is more frequent in males than females. Onset is in childhood. Symptoms often attenuate during late adolescence although a minority experience the full complement of symptoms into mid-adulthood. (From DSM-IV)
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A central nervous system stimulant used most commonly in the treatment of attention-deficit disorders in children and for narcolepsy. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE.
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