A Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with MDD at Imminent Risk of Suicide.
Psychopharmacology bulletin March 4, 2024 Timothy Whitaker, Kimberly F Farrand, Michael E Thase 249 citations
No approved therapy exists for suicidal ideation and behavior (SI/B) in Major Depressive Disorder (MDD), though ketamine shows rapid antidepressant effects. While FDA-approved esketamine reduced suicidality indicators, its effects did not significantly surpass placebo. Racemic ketamine, a mixture of esketamine and arketamine, may better alleviate SI/B. In an open-label study, 17 hospitalized MDD patients with acute SI/B received intranasal racemic ketamine (SLS-002). Treatment significantly reduced depression and suicidality scores on four clinical scales, including the Montgomery-Åsberg Depression Rating Scale and Sheehan-Suicidality Tracking Scale. SLS-002 was well tolerated with an acceptable safety profile, supporting continued development.