A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide
Recruiting in Palo Alto (17 mi)
+28 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Seelos Therapeutics, Inc.
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
Inclusion Criteria
Participant has a Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B) score of ≥4 predose on Day 1.
Participant requires psychiatric hospitalization due to significant risk of suicide, has ≥15 on the S-STS CMCM total score, and a score of 6-9 (inclusive) on the S-STS CMCM Clinician judgment of subject's risk of a suicide attempt or death by suicide at this time.
Participant has a history of previous suicide attempt(s), as confirmed on the Columbia Suicide Severity Rating Scale (C-SSRS) with a history of at least one actual attempt, or if the attempt was interrupted or aborted, is judged to have been serious in intent.
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Treatment Details
Interventions
- SLS-002 (NMDA Receptor Antagonist)
Participant Groups
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
Seelos Investigational SiteSpringfield, IL
Seelos Investigational SiteDecatur, GA
Seelos Investigational SiteBuffalo, NY
Seelos Investigational SiteCincinnati, OH
More Trial Locations
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Who Is Running the Clinical Trial?
Seelos Therapeutics, Inc.Lead Sponsor