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NMDA Receptor Antagonist

SLS-002 for Major Depressive Disorder

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)
Awards & highlights

Study Summary

This trial will test whether the addition of SLS-002 (intranasal racemic ketamine) to standard of care improves symptoms of Major Depressive Disorder and suicidality in participants assessed to be at imminent risk for suicide.

Eligible Conditions
  • Major Depressive Disorder
  • Suicidal

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First 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 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

Find a Location

Who is running the clinical trial?

Seelos Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
416 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Ohio
Florida
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Seelos Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Email
Most responsive sites:
  1. Seelos Investigational Site: < 24 hours
Recent research and studies
clinicaltrials.govStudy
A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide
2020. "A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04669665.
All > Mdd
~54 spots leftby Apr 2025
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