The U.S Food and Drug Administration (FDA) has just completed reviewing an application of an Investigational New Drug (“IND”) from Ehave Inc, a medical provider with special focus on psychedelics and mental health. Consequently, the FDA has approved Ehave’s first-of-a-kind clinical trial investigating intravenous administration of ketamine to treat major depression disorder (MDD). This is an open label study analyzing brain responses (electrographic responses) of patients suffering from major depression prior, during, and after they receive the drug ketamine for a period of four weeks. The ketamine will be administered as an intravenous infusion in a clinical setup.
Ehave’s clinical trial will include 35 participants. These are patients with major depressive disorder who have failed to respond to at least two conventional antidepressants at a sufficient dose and duration. An electroencephalography machine will be used to measure the patients’ brain activities at baseline, during, and after the four weeks of the study period. The lead author of this study is Dr. Jeffrey Kamlet will be working together with Tristar Wellness on this trial. Dr. Kamlet has been the principal investigator in over 20 major pharmaceutical clinical studies.
Over 260 million people globally have experienced a major depressive episode. Severe depression has linked to suicide, the second leading cause of death among the youth (15-29 years). Patients with major depression often fail to respond to conventional treatments.
Preliminary research has shown that ketamine may help to minimize suicidal tendencies, depressive symptoms, and mood fluctuations in severe depression. Intravenous ketamine administration may offer a breakthrough treatment for major depression disorder.
