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: - Participants voluntarily provided informed consent to participate in the study - Participants with written informed consent to participate in the study voluntarily by caregivers/legal representatives - Participants who were capable to follow the study visit schedule well and their parents/caregivers who were willing to complete the assessments specified in the protocol and were capable to complete them - Participant and his/her parent/guardian able to understand the study participation and to request withdrawal from the study voluntarily at any time - Participants who were satisfied in diagnosis of Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) Attention Deficit Hyperactivity Disorder (ADHD) and determined to require drug therapy Are the trial subjects under 18? yes Number of subjects for this age range: 142 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: - Participants who have known hypersensitivity (altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen) to methylphenidate HCL - Participants who have significant suicidal ideation - Participants with mental retardation - Participants who meet DSM-IV diagnostic criteria for current major depressive disorder or anxiety disorder requiring drug therapy - Participants who have abnormalities in the Electrocardiography (ECG) or show clinically significant abnormalities of laboratory results, including serum chemistries and hematology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the safety and efficacy of Osmotic Release Oral System (OROS) methylphenidate in participants with Attention Deficit Hyperactivity Disorder (ADHD).;Secondary Objective: Not applicable;Primary end point(s): - Change From Baseline in Korean Version of the Attention-Deficit Hyperactivity Disorder (K-ADHD) Rating Scale (K-ARS) Total Score at Week 12 - Number of Participants With Response Based on K-ARS Total Score at Week 12 - Number of Participants With Remission Based on K-ARS Total Score and Clinical Global Impression – Improvement (CGI-I) Scale Score at Week 12;Timepoint(s) of evaluation of this end point: - Baseline and/or Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change From Baseline in Child Health and Illness Profile-Child Edition (CHIP) Total Score and 5 Sub-domains Score at Week 12 - Change From Baseline in Visual Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12 - Change From Baseline in Auditory Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12 - Change From Baseline in Inhibition-Sustained Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12 - Change From Baseline in Interference-Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12 - Change From Baseline in Divided Attention Subtest of Comprehensive Attention Test (CAT) at Week 12 - Change From Baseline in Working Memory Forward Subtest of Comprehensive Attention Test (CAT) at Week 12 - Change From Baseline in Working Memory Backward Subtest of Comprehensive Attention Test (CAT) at Week 12 - Change From Baseline in Academic Performance Rating Scale (APRS) Score at Week 12 - Change From Baseline in Beck Depression Inventory (BDI) Score at Week 12 - Change From Baseline in Parenting Stress Index (PSI) Total Score at Week 12 - Change From Baseline in Clinical Global Impression-severity (CGI-S) Score at Week 12 - Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12;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