The ERP Biomarker Qualification Consortium announced today the 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 (located in Marlton, NJ), 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.

Recently, ketamine-like compounds have been a focus of attention across the pharma industry, especially with the market release by Janssen Pharmaceuticals of SPRAVATO® (esketamine) to treat treatment-resistant depression (TRD). Esketamine is a closely-related compound to ketamine and targets some of the same brain networks. Arketamine, another closely-related compound is being trialed by Atai Life Sciences for the treatment of depression.

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.

"We have been studying how ketamine and similar compounds affect brain function in our research labs for many years. This study will enable us to take what we have learned in the lab and make it available to pharma companies who are developing drugs to treat many serious conditions," said Dr. Dan Mathalon, a scientific advisor to the Consortium.

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.

"Combined with our study in subjects with schizophrenia, EBS-A, conducted at CenExel CNS, CenExel HRI, and Columbia University, this repeated-dose design will provide some clarity to the inconsistent results of previous ketamine-challenge studies," said Dr. Marco Cecchi, Scientific Lead for the EBS-B study.

Results of the study will be provided during an upcoming scientific presentation.

 

Source:prnewswire.com

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