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

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

Approved for 5 Other Conditions

All Individual Drugs Already Approved

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 24 hours post first dose

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

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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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