Successful completion of a pharma industry-sponsored study to measure the electrophysiologic effects of ketamine on healthy brain function.

The study (EBS-B) included 24 healthy subjects who made three visits to the CenExel Hassman Research Institute (HRI) study site where they were administered a sub-anesthetic dose of ketamine on two of the three visits and placebo on the other visit. The sequence of ketamine or placebo dosing was randomized across the three subject visits. All subjects were counseled by a site clinician with expertise in ketamine experiences / side effects (e.g., dissociation) before each dosing session, and all sessions were monitored by qualified site staff to monitor participants’ dosing safety. While the subjects were under the effect of ketamine, electroencephalography (EEG) and event-related potential (ERP) recordings were performed using the COGNISION® System. After dosing was discontinued and once the site Principal Investigator (PI) or qualified designee had determined that the subject was no longer under the influence of the ketamine, they were discharged from the clinic.

The primary objectives of the study were to collect data on the electrophysiologic effects of ketamine on brain function and to quantify the variability of those effects across multiple dosing sessions. Ketamine administration is also thought to be a model for the impairments associated with schizophrenia and is used in “ketamine reversal” studies where a novel drug is intended to reverse (or block) the schizophrenic-like effects of ketamine. Quantification of the magnitudes and variability of the EEG/ERP biomarkers collected during this study will facilitate the use of these biomarkers in future studies of ketamine or ketamine-like drugs being developed to target depression, schizophrenia, and other psychiatric and neurological disorders.

Source: Reprint courtesy of PRNewswire, Image courtesy of DCStudio/Freepik Free Lic CC00