From Immediate-release MPH to OROS MPH: The Impact Upon Family of Children and Adolescents With ADHD

Johnson & Johnson Taiwan Ltd0 个研究点目标入组 296 人开始时间: 2015年4月24日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•- 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

•- 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

发起方