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UrduPharma Industry Consortium Completes Brain Wave Study of Ketamine Effects on Healthy Volunteers
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.
About the ERP Biomarker Qualification Consortium
The EBS-B study was sponsored by the ERP Biomarker Qualification Consortium, whose membership includes; Merck, Novartis, AbbVie, Astellas, Lundbeck, Anavex, Sage, Alkermes, Neurocrine, and Takeda. The Consortium is dedicated to performing “precompetitive” studies in neuro-related areas that provide results that benefit large near-term drug programs. These results might include quantification of brain-related deficits that can be used as drug targets, quantification of the brain effects of well-understood compounds, or development of normative databases of brain-based biomarkers. The Consortium also intends to publish all data and results from these studies to provide value across the drug development industry.
About CenExel
CenExel (www.CenExel.com) provides unparalleled medical and scientific support in the design and execution of clinical trials. Our therapeutic area focus, attention to detail, and auxiliary services assure quality, reliable results and help CenExel consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a vast depth of experience and insight for the Principal Investigators and research staff in each facility. The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that their clients achieve their clinical research goals.
