Clinical trial NCT00758160: The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: From Immediate-release MPH to OROS MPH: The Impact Upon Family of Children and Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention Deficit Disorder With Hyperactivity
Methylphenidate
Concerta
Lead sponsor: Johnson & Johnson Taiwan Ltd
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 296
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed description: This is a prospective (study following participants forward in time), single-arm, open-label (all people know the identity of the intervention), 8-week, multi-centric (conducted in more than 1 center) study. OROS-MPH will be administered orally for 2 months at doses of 18, 36, or 54 milligram (mg) to replace IR-MPH. Clinicians will adjust the dose of each participant according to participant's clinical responses and/or side effects. During the study period, participants will be assessed on Week 2, 4, and 8. Efficacy will be evaluated primarily based on change from baseline in Chinese version of the 26-item Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) rating scale assessed by parents and Chinese Health Questionnaire (CHQ). Safety will be monitored throughout the study.

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

Primary outcomes:
measure: Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4
timeFrame: Baseline and Week 4
measure: Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8
timeFrame: Baseline and Week 8
measure: Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4
timeFrame: Baseline and Week 4
measure: Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score
timeFrame: Baseline, Week 4 and 8
measure: Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
timeFrame: Baseline, Week 2, 4 and 8
measure: Social Adjustment Scale Score for Children and Adolescents (SAICA)
timeFrame: Baseline, Week 4 and Week 8
measure: Clinical Global Impression-Severity (CGI-S) Score
timeFrame: Baseline, Week 2, 4 and 8
measure: Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
timeFrame: Baseline, Week 2, 4 and 8
measure: Global Assessment of Satisfaction by Parents/Caregivers
timeFrame: Baseline, Week 2, 4 and 8
Other outcomes:
measure: Global Assessment of Satisfaction by Participant
timeFrame: Baseline, Week 2, 4 and 8
Locations:
Study officials:
affiliation: Johnson & Johnson Taiwan Ltd
name: Johnson & Johnson Taiwan, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: