International Study for the Prediction of Optimized Treatment - in ADHD - iSPOT-A

Brain Resource Company0 个研究点目标入组 194 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

Trial is onging in other countries

•ADHD subjects only: meet DSM-IV criteria for primary diagnosis of ADHD at study entry, ADHD-RS IV score >/ 6 for inattention and/or hyperactivity-impulsivity, candidate for methylphenidate, stimulant naive or stimulant free
•All subjects: males and females between 6-17 years of age, fluent and literate in Dutch or English, signed an informed consent or assent form where required and/or whose parent or legal guardian has provided written informed consent

•ADHD subjects only: known contra-indication to the use of methylphenidate, prior treatment with methylphenidate or any other stimulant medication in the past 7 days, known history of hypersensitivity and/or anaphylaxis to methylphenidate
•Control subjects only: current or previous diagnosis of ADHD or any other psychiatric diagnosis, prior treatment with methylphenidate
•All subjects: pregnancy of child bearing potential who are not using a form of contraception and are at risk of becoming pregnant during the study, known medical condition, disease or neurological disorder which might interfere with the assessment to be made in the study or put ADHD patients at increase risk when exposed to the optimal doses of the drug treatment, history of physical brain injury or blow to the head that resulted in loss of consciousness of greater than 5 minutes, known past or present substance dependence including alcohol, participation in an investigational study within four months of the baseline visit in which subjects have received an experimental drug/device that could affect the primary end points of this study, subjects who have a severe impediment to vision, hearing and/or hand movement, which is likely to interfere with their ability to complete the testing batteries, subjects who are unable and/or unlikely to comprehend and follow the study procedures and instructions, presence of any other co-morbid primary DSM IV disorders

发起方

Brain Resource Company