Attention Deficit Hyperactivity Disorder MedDRA version: 18.0 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder System Organ Class: 100000004873
Conditions
Sponsors
Johnson & Johnson Taiwan Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants who are diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) - Participants who have been treated with Immediate-release methyphenidate (IR-MPH) for at least 4 weeks before enrollment, but previous treatment is considered unsatisfactory due to 1 or more of the following reasons: lack of effectiveness, lack of tolerability or safety, lack of compliance, and/or other reasons - Participants who are able to comply with the study visit schedule and whose parents/caregiver and community school teacher are willing and able to complete the protocol-specified assessments - Participants who are still at school - Participants who are treated with greater than equal to 10 milligram (mg) IR-MPH daily before enrollment Are the trial subjects under 18? yes Number of subjects for this age range: 296 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 cannot understand or follow the instructions given in the study - Participants with serious or unstable medical illness - Participants who have clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract - Participants who have glaucoma (increased pressure inside the eye that causes visual problems), an ongoing seizure disorders, or a psychotic disorder - Participants who are hypersensitive to methylphenidate - Participants who have any co-existing medical condition or are taking a concomitant medication that is likely to interfere with safe administration of methylphenidate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate whether familial relationships and psychological status of participants or caregivers as well as Attention Deficit Hyperactivity Disorder (ADHD) symptoms of participants can be improved by switching from Immediate-release Methylphenidate (IR-MPH) to Osmotic Release Oral Delivery System Methylphenidate (OROS-MPH). ;Secondary Objective: Not applicable;Primary end point(s): - Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 - Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4 - Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8 - Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4 - Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8;Timepoint(s) of evaluation of this end point: - Baseline, Week 2 - Baseline, Week 4 - Baseline, Week 8 - Baseline, Week 4 - Baseline, Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score - Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score - Social Adjustment Score for Children and Adolescents (SAICA) - Clinical Global Impression-Severity (CGI-S) Score - Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score - Global Assessment of Satisfaction by Parents/Caregivers;Timepoint(s) of evaluation of this end point: - Baseline, Week 4, 8 - Baseline, Week 2, 4, 8 - Baseline, Week 4, 8 - Baseline, Week 2, 4, 8 - Baseline, Week 4, 8 - Baseline, Week 2, 4, 8 | — |
Countries
Taiwan
Contacts
Public ContactClinical Registry Group-JB BV
Janssen Research and Development
Outcome results
None listed