EUCTR2015-001216-35-Outside-EU/EEAActive, not recruitingNot Applicable
From Immediate-release MPH to OROS MPH: The Impact Upon Family of Children and Adolescents With ADHD
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Johnson & Johnson Taiwan Ltd
- Enrollment
- 296
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •- 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
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