Status:
COMPLETED
The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
Johnson & Johnson Taiwan Ltd
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
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 pa...
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT00758160
Start Date
March 1 2008
End Date
June 1 2008
Last Update
April 8 2014
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