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NMDA Receptor Antagonist

A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide

Phase 2
Recruiting
Research Sponsored by Seelos Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1, predose) and 24 hours post first dose (day 2)

Summary

This trial is testing a nasal spray with ketamine for people with severe depression who are at high risk of suicide. The spray aims to quickly improve mood by balancing brain chemicals. Esketamine was approved to treat treatment-resistant depression.

Eligible Conditions
  • Major Depressive Disorder
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1, predose) and 24 hours post first dose (day 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1, predose) and 24 hours post first dose (day 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose
Secondary study objectives
Change From Baseline in Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B) Scale at 24 Hours Post First Dose
Change From Baseline in Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B) Scale at Day 16
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 16
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SLS-002 + Standard of careExperimental Treatment3 Interventions
Participants will receive SLS-002 (intranasal racemic ketamine) 90 milligram (mg) two times per week for 2 weeks with standard of care treatment
Group II: Placebo + Standard of carePlacebo Group3 Interventions
Participants will receive intranasal placebo two times per week for 2 weeks with standard of care treatment

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Who is running the clinical trial?

Seelos Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
194 Total Patients Enrolled
~47 spots leftby Dec 2025
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