The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

NCT ID: NCT00758160

Last Updated: 2014-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-06-30

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OROS methylphenidate

Participants willl receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects.

Group Type: EXPERIMENTAL

OROS Methylphenidate

Intervention Type: DRUG

Participants will receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects.

Interventions

OROS Methylphenidate

Participants will receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects.

Intervention Type: DRUG

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Taiwan Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Taiwan, Ltd. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Taiwan Ltd

Other Identifiers

CONCERTAATT4086

Identifier Type: -

Identifier Source: secondary_id

CCT-TWN-MA6

Identifier Type: -

Identifier Source: secondary_id

CR015331

Identifier Type: -

Identifier Source: org_study_id