International Study for the Prediction of Optimized Treatment - in ADHD
- Conditions
- ADHDAttention Deficit/Hyperactivity Disorder10009841
- Registration Number
- NL-OMON33496
- Lead Sponsor
- Brain Resource Company
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 194
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary aim of this study is to establish objective and reliable markers<br /><br>for diagnosis and treatment evaluation. To this aim, treatment response will<br /><br>not simply be measured by change in clinical rating (e.g. Conners), but also<br /><br>through normalization (change from outside to within normal range) of baseline<br /><br>differences in markers. As a complement to previous research using clinical<br /><br>symptoms, markers that improve concurrently with clinical symptoms will be<br /><br>identified through correlation analyses.</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>