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 04, 2024
Source: PubMed
Summary
A promising breakthrough in mental health treatment shows intranasal ketamine can rapidly reduce suicidal thoughts in severe depression. This innovative therapy combines two forms of ketamine in a nasal spray, helping patients with MDD who face immediate suicide risk. In an open label trial, 17 hospitalized patients received racemic ketamine treatment, showing significant improvements in both depression and suicidal thoughts. The treatment proved well-tolerated, offering new hope for rapid intervention in crisis situations.
Abstract
Despite the prevalence of Major Depressive Disorder (MDD) and the propensity of affected individuals to eventually die by suicide, there is no therapeutic approved specifically for suicidal ideation and behavior (SI/B) in MDD. The NMDA receptor antagonist ketamine has been investigated for the treatment of depression and shown to have a rapid effect on symptoms. Spravato® (esketamine) is approved by the FDA for use in treatment-resistant depression and Major Depressive Episodes with Suicidal Ideation based on studies conducted in adults also taking standard antidepressants. While esketamine was associated with a large reduction in suicidality indicators, the effects did not significantly exceed those associated with placebo. Racemic ketamine, a mixture of both esketamine and arketamine, may hold greater potential for the rapid alleviation of SI/B. SLS-002 was developed as an investigational intranasal racemic ketamine for the treatment of SI/B in individuals with MDD. In part one of a two-part clinical trial, the safety, tolerability, and potential effectiveness of SLS-002 were evaluated in an open label study of 17 patients with MDD hospitalized with acute SI/B. Treatment with SLS-002 was associated with a significant reduction in depression and suicidality indicators on four clinical scales: the Montgomery-Åsberg Depression Rating Scale, the Sheehan-Suicidality Tracking Scale, and the Clinical and Patient Global Impression Scales for SI/B. SLS-002 was well tolerated with an acceptable safety profile. The results of this open label study support the continued development of SLS-002. The randomized double-blind placebo-controlled part two of this trial was recently completed.