Showed that treatment with esketamine resulted in a statistically significant, clinically meaningful improvement in depressive symptoms at four hours, including a measure of suicidal ideation, in patients with major depressive disorder who were at imminent risk for suicide, compared to placebo.
Unlike previous clinical trials of antidepressants which typically excluded suicidal patients, this study included people who were severely depressed and actively suicidal.
The study also utilized the Suicide Ideation and Behavior Assessment Tool (SIBAT) to assess suicide risk.
Esketamine nasal spray belongs to a new class of investigational medicines in psychiatry known as glutamate receptor modulators that are thought to help restore synaptic connections in brain cells in people with major depressive disorder.
If approved by the U.S. Food and Drug Administration (FDA) for this indication, esketamine would be the first treatment for patients with major depressive disorder assessed to be at imminent risk for suicide.