Randomized, double-blind (Part 2) placebo-controlled Phase II study (n=164 actual) of intranasal SLS-002 (90 mg, twice weekly for 2 weeks; 4 doses) plus standard of care versus placebo plus standard of care in adults with MDD at imminent risk of suicide.
Two-part study: Part 1 open-label; Part 2 randomized, double-blind, placebo-controlled, parallel-group comparing SLS-002 plus standard of care to intranasal placebo plus standard of care.
Primary outcome is change from baseline in MADRS total score at 24 hours post first dose; safety, tolerability, and suicidality measures are assessed throughout with hospitalisation and clinician-rated instruments used for entry criteria and follow-up.
Dosing regimen in Part 2 is 90 mg intranasal racemic ketamine delivered via device two times per week for 2 weeks (4 total administrations), given with concomitant standard of care determined by treating clinicians.
Intranasal SLS-002 plus standard of care; 90 mg intranasal dosing two times per week for 2 weeks.
Intranasal racemic ketamine delivered via intranasal device; 90 mg per administration.
Standard of care (treatment determined by treating physician).
Intranasal placebo plus standard of care; matched schedule.
Intranasal placebo via device.
Standard of care (treatment determined by treating physician).