Information for Clinicians - iSPOT-A study (ADHD)

 

On this webpage you can find more information about the iSPOT-A study. 

 

Participation of your patient

 

Before considering if your patient is eligible for participation, it is important to determine whether the use of short-acting methylphenidate is indicated. If this is the case your patient and his / her parents / guardian will be invited to Brainclinics for the screening location and first assessments. The screening consists of a psychological interview to determine the diagnosis and to exclude other comorbid developmental disorders. Subsequently, the neurophysiological (EEG, ECG, ERPs), genetic  (saliva collection) and neuropsychological measurements will be assessed. The first study day will cost your patient approximately 5 to 6 hours. After completing the measurements on the first day, your patient can start with his/her treatment with methylphenidate (e.g. Ritalin, Concerta). 

After 6 weeks the patient returns to Brainclinics for the same measurements as on the first day. During the rest of the year, the treatment, side effects, concomitant medication and the occurrence of any adverse events will be evaluated by telephone interviews and internet questionnaires. These evaluations are planned in week 24 and week 52 of the study. Your patient and his/her parents/guardian will receive financial compensation for their participation.

 

Your co-operation

 

Your patient should be treated with methylphenidate within a few days after the first measurements. Patients who already use methylphenidate can participate as well if they are able to interrupt their treatment for seven days prior to the first measurements. The treatment will be executed by you.

 

And what else?

 

All steps of the treatment will be carried out without any intervention by the study, thus this is a non-interventional and naturalistic study. Medication is not provided by Brainclinics and the patient remains under responsibility of his/her treating physician.

In the event we learn of relevant medical information (e.g. severe side effects) the research team will contact you immediately. If you are interested we can send you a report containing results of questionnaires and neuropsychological tests.

 

About the iSPOT studies

 

Research institute Brainclinics is focuses on applied research in the field of 'personalized medicine'. The research team consist of clinical, neuro- and biological psychologists, each with their own involvement in the execution of the measurements. The intention for next 3 years in the Netherlands is to include 125 patients with depression into the study. Internationally, a total of more than 1,300 ADHD patients will be examined. The sponsor of this study is the 'Brain Resource Company', an Australian biotech company that focuses on research and developments in the field of 'personalized medicine '. Therefore, there is no funding from the pharmaceutical industry. The trial is registered in the NIH Trial Registry and has great interest from the FDA. Both the CCMO and the medical ethics committee have authorized this study. More information on the iSPOT-D study in Depression can be found here.