Attention Deficit Hyperactivity Disorder MedDRA version: 18.0 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder System Organ Class: 100000004873
Conditions
Sponsors
Janssen Korea Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Guardian has provided a written consent for subject - Male and female patients from 6 to 18 years of age - Subject diagnosed with ADHD by K-SADS-PL(Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version- Korean Version), and it is determined that he/she requires drug therapy - Able to observe the study’s visit schedule, and the subject and his/her parent/guardians are willing and able to complete the evaluation defined in the Clinical Protocol during the treatment period - Subject/guardian who can understand the participation in the study and spontaneously request discontinuation of the study anytime Are the trial subjects under 18? yes Number of subjects for this age range: 145 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subject who was administered with Methylphenidate HCl besides Concerta® within 24 hrs of study participation - Subject who was administered with Concerta within the recent three months - Subject who is known to have hypersensitivity to Methylphenidate HCI or other ingredient of this product - Subject who was administered with the following medications within the last 4 weeks: clonidine or alpha-2 adrenergic receptor agonist, anti-depressants like TCAs or SSRIs (except for Fluoxetine, a subject administered with the drug within 12 weeks is included in the exclusion criteria.), theophylline, coumarin or anticonvulsants, anti-psychotics, benzodiazepines, modafinil - Subject with clinically significant GI problem with a possibility of GI tract obstruction including GI tract stenosis (by pathological or doctor’s diagnosis). For example, intestinal inflammation, short gut syndrome due to adhesion or decrease of transit time, previous history of peritonitis, cystic fibrosis, chronic intestinal pseudo-obstruction or Meckel’s diverticulum - Subject with glaucoma, current seizure disorders like epilepsy, mental disease, Tourette’s syndrome, cardiovascular disease including moderate to severe hypertension, excessive agitation or restlessness, or hyperthyroidism - Subject with other accompanying disease that could inhibit the safe administration of methylphenidate, or subject who is administered with such concomitant drugs - Subject unable to swallow the investigational product - When drug abuse is currently known or suspected, or subject has a history of drug abuse - Subject with mental retardation (IQ of less than 70) - Subject with high risk of pregnancy - Subject either started or changed to a new behavioral therapy for ADHD during the study period - Subject with overall developmental disorder - Subject who is taking oriental herbal medicines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the optimal dosages of Osmotic Release Oral System (OROS) methylphenidate in participants with Attention Deficit Hyperactivity Disorder (ADHD).;Secondary Objective: To evaluate the overall efficiacy and safety of Osmotic Release Oral System (OROS) methylphenidate on the improvement of Attention Deficit Hyperactivity Disorder symptoms;Primary end point(s): - Dupaul ADHD Rating Scale (K-ARS);Timepoint(s) of evaluation of this end point: - Baseline and/or Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - ADS - IOWA CPRS - CDI (Children’s Depression Inventory) - STAIC (State-Trait Anxiety Inventory for Children) - YGTSS (Severity) - LPS-C - APRS (Academic Performance Rating Scale) - CGI (Clinical Global Impression);Timepoint(s) of evaluation of this end point: - Baseline and/or Week 12 | — |
Countries
Korea, Republic of
Contacts
Public ContactClinical Registry Group-JB BV
Janssen Research and Development
Outcome results
None listed