Information for Clinicians - iSPOT-D study (depression)

 

If your patient is interested in participating in the iSPOT-D study, you can find more information here.

The iSPOT-D (International Study to Predict Optimized Treatment for depression) study is a large depression phase 4 study for the efficacy and optimization of the use of antidepressants. The purpose of the study is to discover biomarkers - ie indicators that can determine whether a person will benefit from treatment with a particular type of antidepressant or not. For this study we look for patients with a depression for whom treatment with an antidepressant is indicated. The antidepressants used in this study are: venlafaxine, escitalopram and sertraline.

 

 

Participation of your client

First your patient will undergo an extensive psychological interview and a tox screen to verify that he/she meets all  criteria. If your patient meets all criteria, neurophysiological (EEG, ECG, ERPs), genetic and neuropsychological measurements will be done. These measurements will take approximately 6 hours. After that the patient starts treatment with antidepressant medication. After 8 weeks, the patient returns to Brainclinics for the same measurements we did on the first day. Also the use of the medication and the concomitant occurrence of any adverse events during the year are evaluated by phone and Internet questionnaires. Your patient will receive a financial compensation for his/her participation.
 


Your co-operation

The cooperation we ask is for you to prescribe the antidepressant which is randomized by the study (this study is approved by the medical ethics committee: IRBN Nijmegen). Therefore, your patient must be potentially suitable for each of the three used antidepressants (venlafaxine, escitalopram and sertraline), to be currently experiencing a depression and have the age of between 18 and 65 years. When the patient has completed the first measurements, he/she gets a letter with the antidepressant he/she is going to use. If you wish we can also have contact by phone. Goal is that within a few days after the initial measurements, the prescription can be picked up so the patient can start his/her treatment. 

 

 

What else?

If both, you and your patient, are willing to participate, please let your patient contact us. We then will do a telephone screening and schedule the first measurement. You will be informed when these measurements will take place. 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 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 the next 2 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.