Ketamine for MDD with Acute Suicidality

Purpose: To assess the efficacy, safety, and tolerability of SLS-002, an intranasal ketamine, administered to adults with MDD who are also at imminent risk of suicide.

Inclusion Criteria

• 18-65 years old
• Diagnosed with MDD (unipolar without psychotic features), with symptoms present for a minimum of 4 weeks
• MADRS total score of greater than or equal to 28 on Day 1 predose
• Requires psychiatric hospitalization as a result of significant suicide risk
• Current suicide ideation with intent confirmed by the MINI Suicidality Module

Exclusion Criteria

• Ongoing persistent symptoms of prior COVID illness, or symptoms suggestive of recent COVID infection within one month of screening
• Lifetime diagnosis of bipolar disorder or any mood disorder with psychotic features, schizophrenia, OCD, ASPD, or BPD
• Chronic, refractory TRD to more than 4 adequate therapeutic trials of antidepressants
• History of ketamine or esketamine use for any psychiatric treatment