An Open-label Prospective Trial to Evaluate Functional Outcomes of OROS Methylphenidate in Children with ADHD (FOSCO)

Janssen Korea Ltd0 个研究点目标入组 142 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 voluntarily provided informed consent to participate in the study
•- Participants with written informed consent to participate in the study voluntarily by caregivers/legal representatives
•- Participants who were capable to follow the study visit schedule well and their parents/caregivers who were willing to complete the assessments specified in the protocol and were capable to complete them
•- Participant and his/her parent/guardian able to understand the study participation and to request withdrawal from the study voluntarily at any time
•- Participants who were satisfied in diagnosis of Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) Attention Deficit Hyperactivity Disorder (ADHD) and determined to require drug therapy
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 142
•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 have known hypersensitivity (altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen) to methylphenidate HCL
•- Participants who have significant suicidal ideation
•- Participants with mental retardation
•- Participants who meet DSM-IV diagnostic criteria for current major depressive disorder or anxiety disorder requiring drug therapy
•- Participants who have abnormalities in the Electrocardiography (ECG) or show clinically significant abnormalities of laboratory results, including serum chemistries and hematology

发起方