Ehave, Inc. announced that it received confirmation from the U.S. Food and Drug Administration that its review of Investigational New Drug application is complete. The FDA authorized Ehave to proceed with its clinical study, "An open label study of electrographic responses pre, during and post, a low dose, weekly intravenous ketamine infusion for 4 weeks, in a study population with major depression disorder submitted under section 505 of the Federal Food, Drug, and Cosmetic Act for Ketamine HCl. The objective of this study is to characterize the change in EEG response of patients with MDD, during and 4 weeks after a course of IV ketamine infusions.

The clinical study includes 35 participants with Major Depression Disorder. It will include subjects with an inadequate response to at least two FDA-approved antidepressant therapies, including the current course of antidepressant therapy, at a sufficient dose and duration for the current episode. An electroencephalography machine measures the brain's activity at baseline and after four weekly low-dose IV ketamine study treatments.

The purpose of the study is to learn about the neurological responses seen on EEGs of participants receiving low-dose IV ketamine therapy. Dr. Jeffrey Kamlet and Tristar Wellness will complete the study. Dr. Kamlet has served as the principal investigator on more than 20 major pharmaceutical trials.

More than 264 million people across the globe suffer from depression. As a pervasive and often chronic health condition, depression is a global health burden and a significant source of disability. While depression might be considered a non-fatal health burden, severe depressive symptoms can lead to suicide, which is the second most common cause of death in people aged 15-29 years.

Common treatments for depression include pharmacological interventions such as selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors and tricyclic antidepressants and psychotherapy; however, the efficacy of these interventions often fails in severe cases. Ketamine is a dissociative anesthetic, used most frequently in veterinary medicine and pediatrics, that has been repurposed as an off-label analgesic and antidepressant. Extensive investigation of its rapid antidepressive effects have been a breakthrough offering a potential reprieve to those suffering from MDD.

Ketamine has also been shown to reduce suicidal ideation in depressed patients at risk for suicide. Similarly, the administration of ketamine was effective at reducing depressive symptoms, acute suicidal behavior, and mood lability in the youth with treatment-resistant depression and bipolar disease. Intranasal esketamine is the only form of ketamine that has been FDA-approved as a treatment for TRD.

However, clinical research and real-world feasibility have established significant drawbacks to intranasal ketamine, including patient discomfort with administration, greater risk of diversion to the illicit market, and potentially serious adverse reactions. Intravenous use of racemic ketamine is the more established route of administration as it has long been used as an anesthetic at much higher doses. Ehave management believes intravenous administration of ketamine includes benefits which include greater dose control and reduced cost of drug acquisition.

This belief is the fundamental premise that has led to many dedicated outpatient clinics offering intravenous ketamine therapy for MDD across the United States.