The primary objectives of the iSPOT-A trial are to use Brain Resource's standardized 'Integrative Neuroscience' test batteries to 1) Identify objective markers of ADHD compared with healthy controls, using cognitive, brain and genetic…
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim of this study is to establish objective and reliable markers
for diagnosis and treatment evaluation. To this aim, treatment response will
not simply be measured by change in clinical rating (e.g. Conners), but also
through normalization (change from outside to within normal range) of baseline
differences in markers. As a complement to previous research using clinical
symptoms, markers that improve concurrently with clinical symptoms will be
identified through correlation analyses.
Secondary outcome
NA
Background summary
ADHD is a common psychiatric disorder in children and adolescents and typically
has severe consequences for the individual, including difficulties in school or
work, increased risk of drug abuse and severe accidents. It also commonly
impacts on the family and surrounding community, including a significant
financial cost for treatment and familial stress and breakdown.
A large majority of ADHD individuals (75-90%) are treated with stimulant
medication at some stage of the disorder. Yet, the use of stimulants has been
associated with significant disadvantages in terms of efficacy, potential
safety and public perception. It has been reported that up to 30% of ADHD
patients do not respond positively to stimulants. Thus, there is a need to
identify objective markers of stimulant efficacy.
Study objective
The primary objectives of the iSPOT-A trial are to use Brain Resource's
standardized 'Integrative Neuroscience' test batteries to 1) Identify objective
markers of ADHD compared with healthy controls, using cognitive, brain and
genetic markers
2) Identify objective markers that best predict treatment response (defined by
active symptom remission) to methylphenidate (immediate release formulation)
using cognitive, brain and genetic markers.
Study design
This is an open-label study. A control group constitutes of healthy controls.
Study burden and risks
There is a time investment of two times 5-6 hours of assessments at
Brainclinics (psychological interview, questionnaires, QEEG and
neuropsychological assessment, collection of saliva, tox/preganancy test) as
well as two times clinical monitoring (telephone interview and questionnaires)
of around 40 minutes of duration.
The risks of the study procedure are limited to possible skin irritation as a
result of Quickgel use for the EEG assessment.
The treatment of ADHD with short-acting methylphenidate can cause a variety of
side-effects. The research staff will discuss this with the parents and
children. However, since it concerns treatment as usual, the side-effects are
not associated with the procedures of the study itself.
There are no direct benefits for subjects who participate. However, parents and
teachers can get a standardized Conners report will which shows course of
symptoms over the time and which can demonstrate improvement/non improvement as
a result of treatment.
235 Jones Street
Ultimo 2007, NSW
AU
235 Jones Street
Ultimo 2007, NSW
AU
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-013272-47-NL |
| ClinicalTrials.gov | NCT00863499 |
| CCMO | NL28450.072.09 |