International study project of optimal treatment in ADHD disorder
The International Study Project for Optimal Treatment of Attention Deficit/Hyperactivity Disorder is a project aimed at identifying objective indicators of treatment response in individuals with this disorder (compared to healthy individuals) using measures of cognitive and brain functions, brain structure, and genetic measurements. These objective indicators can increase the accuracy and sensitivity of the assessment in diagnosis and the capacity to predict the response to treatment.
The International Study to Predict Optimized Treatment – in ADHD (iSPOT-A) is a multicenter, international, prospective, open-label effectiveness trial that aims to identify objective indicators of treatment response in ADHD subjects (versus healthy controls) using cognitive and brain function measures, brain structure and genetic measures.
iSPOT-A uses clinical, cognitive, functional, structural and genomic brain and body measures to identify objective markers of ADHD that predict treatment response and non-response. These objective markers may increase the sensitivity and specificity of both assessment of ADHD (supporting diagnosis) and the capacity to predict response to treatment. This will help to personalize the treatment of ADHD as clinicians will be equipped with the tools to prescribe methylphenidate medication for to suitable individuals with ADHD.
Currently there are 6 sites across the globe participating in this effectiveness trial. Across these sites a total of at least 672 naive and treatment experienced, albeit washed-out, subjects with ADHD (aged 6-17) will be enrolled. In addition, up to 672 healthy (non-ADHD) control subjects will be recruited who match the enrolled ADHD subjects in race, age, gender and years of education. As part of the study, subjects will be required to attend at least two assessment visits, one a baseline and one at week 6, in addition to completing two follow-up assessments at week 24 and 52 via telephone and internet. ADHD participants will be supplied with open-label methylphenidate via a prescription.
The iSPOT-A initiative is sponsored by Brain Resource Ltd. (with offices in San Francisco, USA and Sydney, Australia). The Sponsor Principal Investigator is Dr Evian Gordon and the trial is managed centrally by a Brain Resource Team.
In parallel the trial is under an independent academic structure with a Publication Committee chaired by Prof Glen Elliott. Dr Leanne Williams was the Academic Principal Investigator for iSPOT-A from 2008 to 2013.
Principal Investigators at each site include:
USA: Barbara Cohen, PhD Center for Healing the Human Spirit, California; Roger deBeus, PhD Skyland Behavioral Health Associates, North Carolina; Kamran Fallahpour, PhD Brain Resource Center, NYC; Harban Multani (current) James Rosenthal (past), MD Shanti Clinical Trials Colton, California and Mona Ismail, MD Brain Resource Center, New Jersey.
Australia: Simon Clarke, MD PhD Sydney University Brain Dynamics Centre and Michael Kohn, MD PhD Westmead Children’s Hospital.
Netherlands: Martijn Arns, PhD Brainclinics Diagnostics & Treatment, Nijmegen