Attention Deficit Hyperactivity Disorder MedDRA version: 18.0 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder System Organ Class: 100000004873
Conditions
Interventions
Trade Name: CONCERTA
Product Name: CONCERTA
Pharmaceutical Form: Prolonged-release capsule
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
CAS Number: 298-59-9
Concentration unit: mg milligram(s)
C
Sponsors
Janssen-Cilag Taiwan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients who used to be treated their Attention-deficit hyperactivity disorder with IR-MPH less than 70 mg/day (inclusive) for at least one month without severe adverse events or possible contraindications with MPH - Patients must be living with the parent/caregiver who can complete the questionnaires during the study - Patients or parent/caregiver without any psychotic disease or any mental situation which may cause the concern to properly complete the questionnaires Are the trial subjects under 18? yes Number of subjects for this age range: 520 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 520 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Known to be non-responders to methylphenidate - Marked anxiety, tension, aggression/agitation - Known or suspected mental retardation or significant learning disorder - Glaucoma, ongoing seizure disorder, psychotic disorder, diagnosis or family history of Tourette's disorder, bipolar disorder, eating disorder - Subject who require drug therapy or hospitalization for treatment of a mood or anxiety disorder - other psychotropic medication subject is taking at study entry could be continued during study period they were maintained at a stable dose for a minimum of 4 weeks pre-study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the study is to investigate the clinical benefit of switching children with ADHD from immediate-release methylphenidate (IR-MPH) to OROS-methylphenidate under the correct dosage conversion scheme.;Secondary Objective: Not applicable;Primary end point(s): To investigate the final dosage of OROS-methylphenidate for patients achieving optimal response in 10 weeks.The optimal response is defined as a score of 0 or 1 on each of the first 18 ADHD items (referred to SNAP-IV (Swanson, Nolan and Pelham));Timepoint(s) of evaluation of this end point: 10 wks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To describe the measurement of symptom(s)/sign(s) quality of life improvement and to describe the efficacy and the global assessment of satisfaction by parents/caregivers and patients at every visit throughout the study in 10 weeks.;Timepoint(s) of evaluation of this end point: Every visit throughout study | — |
Countries
Taiwan
Contacts
Public ContactClinical Registry Group-JB BV
Janssen Research and Development
Outcome results
None listed