atai Life Sciences N.V. 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. 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 its currently available treatments, as well as the likelihood that these patients' brains are less capable of change in ways that improve mental health.