Phase 4
N=296
The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Disorder With Hyperactivity
Bottom Line
View on ClinicalTrials.gov: NCT00758160 ↗Enrolled (actual)
296
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 — 1.7; 1.4; 1.3; -0.4 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- OROS Methylphenidate (Drug)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Taiwan Ltd
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 |
1.7; 1.4; 1.3; -0.4; -0.3; -0.3 | — |
| PRIMARY Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4 |
-0.4; -0.3; -0.3 | — |
| PRIMARY Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8 |
-0.5; -0.4; -0.4 | — |
| PRIMARY Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4 |
1.9; 1.7; -0.1; 0 | — |
| PRIMARY Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8 |
-0.1; 0 | — |
| SECONDARY Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score |
6.4; 6.5; 6.6; 6.7; 6.5; 6.6 | — |
| SECONDARY Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score |
1.5; 1.1; 0.9; 1.3; 0.9; 0.7 | — |
| SECONDARY Social Adjustment Scale Score for Children and Adolescents (SAICA) |
1.5; 1.8; 1.8 | — |
| SECONDARY Clinical Global Impression-Severity (CGI-S) Score |
4.3; 3.5; 3.1; 3.0 | — |
| SECONDARY Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score |
4; 98; 126; 45; 16; 2 | — |
| SECONDARY Global Assessment of Satisfaction by Parents/Caregivers |
3.1; 3.4; 3.7; 3.6 | — |
Summary
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).
Eligibility 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
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
Data sourced from ClinicalTrials.gov (NCT00758160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.