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NMDA Receptor Antagonist

SLS-002 for Depression

Phase 2
Waitlist Available
Led By Paul Kim, MD, PhD
Research Sponsored by Johns Hopkins University
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 and 24 hours post first dose
Awards & highlights

Summary

This trial is testing a nasal spray with ketamine to help adults with severe depression who are at risk of suicide. The spray works by quickly changing brain activity to improve mood and reduce suicidal thoughts. Esketamine, a form of ketamine, was approved to treat difficult-to-treat depression.

Eligible Conditions
  • Depression
  • Suicidal Ideation
  • Suicidal Thoughts

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 24 hours post first dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 24 hours post first dose 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-Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours Following Initial 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 Following Initial 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
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 90mg SLS-002 plus Standard of careExperimental Treatment2 Interventions
Participants will receive 90mg SLS-002 (intranasal racemic ketamine) two times per week for 16 days including standard of care treatment. Total of 5 doses of SLS-002.
Group II: Placebo plus Standard of carePlacebo Group2 Interventions
Participants will receive intranasal placebo two times per week for 16 days plus standard of care treatment for a total of 5 doses.

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Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,899 Total Patients Enrolled
57 Trials studying Depression
29,545 Patients Enrolled for Depression
Seelos Therapeutics, Inc.Industry Sponsor
5 Previous Clinical Trials
642 Total Patients Enrolled
1 Trials studying Depression
236 Patients Enrolled for Depression
Paul Kim, MD, PhDPrincipal InvestigatorJohns Hopkins Hospital Department of Psychiatry and Behavioral Sciences
1 Previous Clinical Trials
~3 spots leftby Sep 2025
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