atai Life Sciences N.V. (NASDAQ: ATAI), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced it has initiated a clinical study with Massachusetts General Hospital (MGH).

The study will utilize a neuroimaging method to identify neuroplasticity biomarkers in patients with treatment-resistant depression (TRD) undergoing intravenous (IV) ketamine treatment. The main objective of this study will be to develop a novel method to detect neuroplasticity through magnetic resonance imaging (MRI) scans, electroencephalogram (EEG) collection and clinical assessments. The study will identify changes in the brain at baseline, 24-48 hours post-treatment, and 2 weeks after ketamine administration. The availability of a validated protocol to measure structural plasticity at the neuronal level in the human brain would be a great advancement to the field of neuroplasticity research and may represent a potential tool for drug developers, researchers, and providers as an early biomarker of treatment response and efficacy.

“The study results will help guide atai’s efforts to discover personalized mental health treatments. Novel imaging biomarkers during ketamine treatment will enable a deeper understanding of the therapeutic mechanisms of action (MoA) and the pathophysiology of TRD. This knowledge can potentially help improve patient outcomes by informing if and how patients are responding to treatment and eventually which patients will most benefit from treatment. The highly experienced team and technological resources at MGH will be invaluable in this endeavor.”

atai’s Chief Medical Officer, Rolando Gutiérrez-Esteinou, MD

Nearly half of the $350 billion spent every year in the U.S. on mental healthcare is attributable to treatment-resistant patients: those who do not experience relief from their symptoms despite multiple treatments. Treatment resistance reflects both the limitations of our currently available treatments, as well as the likelihood that these patients’ brains are less capable of change in ways that improve mental health.

MGH is Harvard Medical School’s largest teaching hospital. Their Intravenous Ketamine Clinic for Depression offers access to ketamine treatment for severe and refractory depression. And these new brain imaging technologies available at MGH through the support of this study will allow scientists advanced neuroimaging tools and methods to see the neuroplastic effects of fast-acting drugs like ketamine.

Dr. Cristina Cusin, Associate Professor in Psychiatry at Harvard Medical School, Director of the MGH Ketamine Clinic and Psychiatrist at the Depression Clinical and Research Program, and Dr. Susie Huang, Associate Professor of Radiology at Harvard Medical School and Attending Radiologist in the Division of Neuroradiology and Athinoula A. Martinos Center for Biomedical Imaging in the Department of Radiology at the Massachusetts General Hospital, will serve as co-investigators for the study.

Dr. Cusin said of the collaboration, “We are committed to providing excellent care to patients in need. A critical piece of this is conducting ground-breaking research. We look forward to embarking on this clinical study to help develop new tools to understand the biological changes occurring in depression, which, in turn, may lead to better and faster diagnosis, more personalized treatments and better outcomes.”

About atai Life Sciences

atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.

By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients.

About Massachusetts General Hospital

Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The Mass General Research Institute conducts the largest hospital-based research program in the nation, with annual research operations of more than $1 billion and comprises more than 9,500 researchers working across more than 30 institutes, centers and departments. In July 2022, Mass General was named #8 in the U.S. News & World Report list of “America’s Best Hospitals.” MGH is a founding member of the Mass General Brigham healthcare system.