Esketamine Shows Robust, Rapid Effect in Treatment-Resistant Depression
Patients with treatment-resistant depression experienced a rapid and robust antidepressant effect after a 40-minute IV infusion of esketamine, according to a study in the September 15 issue of Biological Psychiatry. Esketamine is a component of the general anesthetic ketamine.
Researchers from Janssen Research & Development compared the safety and efficacy of 2 doses of esketamine (0.2 mg/kg and 0.4 mg/kg) against placebo in a study involving 30 patients with treatment-resistant depression. In a weeklong double-blind phase, patients were randomly assigned 2 IV doses. During a 2-week follow-up phase, patients had the option to receive up to 4 additional open-label doses.
More than 60% of patients who received either dose of esketamine experienced improvement in depressive symptoms within 3 days, researchers reported. The earliest antidepressant effect occurred just 2 hours after the first IV infusion. Meanwhile, none of the patients who received placebo experienced a response.
MORE: Study Assesses How Long the Antidepressant Effects of Ketamine Last
Adverse effects were dose-dependent, according to the study. Perceptual changes immediately after infusion were reported by 17% of patients taking the higher esketamine dose but resolved within 4 hours.
“The study shows clear benefits of the drug over placebo and suggests that the lowest of the 2 doses may be equally efficacious but also safer,” said Murray Stein, MD, the University of California San Diego, and a deputy editor of Biological Psychiatry.
“Though the mechanism of ketamine (and esketamine) antidepressant effects remains unclear, this study clearly demonstrates a benefit, at least in the short term, of this drug for treatment-resistant depression,” said Dr. Stein.
MORE: Ketamine to Be Tested as Treatment for Alcoholics
Last month, the US Food and Drug Administration (FDA) granted Janssen Research & Development a second breakthrough therapy designation for intranasal esketamine for patients with major depressive disorder at imminent risk for suicide. The agency granted the first breakthrough therapy designation for the investigational compound in November 2013.
“This designation reinforces the potential of esketamine as a novel treatment for patients with major depressive disorder who are at imminent risk for suicide, a condition for which there currently is no approved treatment and which represents a major public health challenge,” said Husseini K. Manji, MD, global therapeutic head for neuroscience at Janssen.
“We are currently conducting clinical trials to further evaluate the clinical benefit of esketamine and look forward to working closely with the FDA throughout the development and review process to bring this important potential new therapy to patients in critical need.”
– Jolynn Tumolo
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