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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 will test whether adding the drug ketamine to standard care can help relieve symptoms of depression and suicidality in adults with Major Depressive Disorder who are at imminent risk for suicide.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours Following Initial Dose
Secondary outcome measures
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
2,285 Previous Clinical Trials
14,843,055 Total Patients Enrolled
57 Trials studying Depression
29,605 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 Jul 2025
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